Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 10:56 PM
Study NCT ID:
NCT02053493
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2014-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030397', 'term': 'isosorbide-5-mononitrate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Adrian.Hernandez@duke.edu', 'phone': '919-668-7515', 'title': 'Dr. Adrian Hernandez', 'organization': 'Duke Clinical Research Insitute'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Informed Consent through Week 15 phone visit', 'description': 'Per protocol, non-serious AEs were not collected; all SAEs were collected except for anticipated, disease-related events in patients with HF with preserved EF.\n\n3 time points summarized: Informed Consent to start of Phase 1 study drug, Phase 1 study drug start to start of Phase 2 study drug, Phase 2 study drug start to Week 15 phone call.', 'eventGroups': [{'id': 'EG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Cellulitis', 'notes': 'Phase 1 study drug start to start of Phase 2 study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'chronic obstructive pulmonary disease', 'notes': 'Phase 2 study drug start to Week 15 phone call', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Herpes Zoster', 'notes': 'Phase 2 study drug start to Week 15 phone call', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Faecaloma', 'notes': 'Informed consent to start of phase 1 study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary retention', 'notes': 'Informed consent to start of phase 1 study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Arbitrary Accelerometry Units (AAU) (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '9370', 'spread': '4601', 'groupId': 'OG000'}, {'value': '9538', 'spread': '6286', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5-6 weeks', 'description': 'To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.', 'unitOfMeasure': 'accelerometry units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'Six Minute Walk Distance (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '307.8', 'spread': '125.5', 'groupId': 'OG000'}, {'value': '327.1', 'spread': '126.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 7', 'description': 'To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'Six Minute Walk Distance (Phase II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '321.3', 'spread': '132.4', 'groupId': 'OG000'}, {'value': '329.7', 'spread': '132.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 13', 'description': 'To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'Patient Preference for Isosorbide Mononitrate Treatment at the End of Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'title': 'Phase1', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Phase2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 13', 'description': 'Self reported participant preference for study period 1 vs. study period 2.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'Borg Score During 6 Minute Walk Test (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 7', 'description': 'To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'Borg Score During 6 Minute Walk Test (Phase II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 13', 'description': 'To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'spread': '23.4', 'groupId': 'OG000'}, {'value': '64.2', 'spread': '24.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 7', 'description': 'To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'spread': '23.6', 'groupId': 'OG000'}, {'value': '61.6', 'spread': '23.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 13', 'description': 'To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. • The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).Higher values of the overall KCCQ score are considered to be better than lower values.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'PRIMARY', 'title': 'Arbitrary Accelerometry Units (AAU) (Phase II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '8824', 'spread': '3877', 'groupId': 'OG000'}, {'value': '8900', 'spread': '5457', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '11-12 weeks', 'description': 'To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.', 'unitOfMeasure': 'accelerometry units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'N-terminal Pro-B-type Natriuretic Peptide Level (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '513.0', 'spread': '803.2', 'groupId': 'OG000'}, {'value': '542.4', 'spread': '710.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 7', 'description': 'To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'N-terminal Pro-B-type Natriuretic Peptide Level (Phase II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '466.1', 'spread': '677.4', 'groupId': 'OG000'}, {'value': '573.3', 'spread': '756.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 13', 'description': 'To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'Improvement in Daily Activity - Hours Active Per Day (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5-6 weeks', 'description': 'To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug', 'unitOfMeasure': 'Hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'Improvement in Daily Activity - Hours Active Per Day (Phase II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '11-12 weeks', 'description': 'To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug', 'unitOfMeasure': 'Hours/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'Improvement in Daily Activity - Slope of Daily Average (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '26.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-6 weeks', 'description': 'To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.', 'unitOfMeasure': 'accelerometry units/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'Improvement in Daily Activity - Slope of Daily Average (Phase II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '16.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9-12 weeks', 'description': 'To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.', 'unitOfMeasure': 'accelerometry units/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'Improvement in Daily Activity - Area Under the Curve (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '9621.4', 'spread': '4367.8', 'groupId': 'OG000'}, {'value': '9714.0', 'spread': '6273.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-6 weeks', 'description': 'To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7\\*average acceleromtery units/day during 30 mg) + (7\\*average acceleromtery units/day during 60 mg) + (14\\*average acceleromtery units/day during 120 mg))/28', 'unitOfMeasure': 'accelerometry units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}, {'type': 'SECONDARY', 'title': 'Improvement in Daily Activity - Area Under the Curve (Phase II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'OG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '9146.5', 'spread': '3695.3', 'groupId': 'OG000'}, {'value': '9325.9', 'spread': '5668.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9-12 weeks', 'description': 'To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7\\*average acceleromtery units/day during 30 mg) + (7\\*average acceleromtery units/day during 60 mg) + (14\\*average acceleromtery units/day during 120 mg))/28', 'unitOfMeasure': 'accelerometry units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with usable data included in the results'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'FG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'All patients admitted to the participating HFN centers with signs and symptoms suggestive of HFpEF will be screened including their ability to wear the accelerometer belt. Patients meeting eligibility criteria will be approached regarding participation in this study.', 'preAssignmentDetails': 'All subjects who fulfill all the inclusion criteria and none of the exclusion criteria will undergo the baseline studies and then be randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Isosorbide Mononitrate Crossover to Placebo', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nIsosorbide Mononitrate: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN'}, {'id': 'BG001', 'title': 'Placebo Crossover to Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)\n\nPlacebo: Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.8', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '68.8', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '69.3', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2014-01-03', 'resultsFirstSubmitDate': '2016-02-04', 'studyFirstSubmitQcDate': '2014-01-31', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-07', 'studyFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arbitrary Accelerometry Units (AAU) (Phase I)', 'timeFrame': '5-6 weeks', 'description': 'To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.'}, {'measure': 'Arbitrary Accelerometry Units (AAU) (Phase II)', 'timeFrame': '11-12 weeks', 'description': 'To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.'}], 'secondaryOutcomes': [{'measure': 'Six Minute Walk Distance (Phase I)', 'timeFrame': 'Week 7', 'description': 'To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.'}, {'measure': 'Six Minute Walk Distance (Phase II)', 'timeFrame': 'Week 13', 'description': 'To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.'}, {'measure': 'Patient Preference for Isosorbide Mononitrate Treatment at the End of Study.', 'timeFrame': 'Week 13', 'description': 'Self reported participant preference for study period 1 vs. study period 2.'}, {'measure': 'Borg Score During 6 Minute Walk Test (Phase I)', 'timeFrame': 'Week 7', 'description': 'To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.'}, {'measure': 'Borg Score During 6 Minute Walk Test (Phase II)', 'timeFrame': 'Week 13', 'description': 'To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.'}, {'measure': 'Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase I)', 'timeFrame': 'Week 7', 'description': 'To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).'}, {'measure': 'Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase II)', 'timeFrame': 'Week 13', 'description': 'To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. • The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).Higher values of the overall KCCQ score are considered to be better than lower values.'}, {'measure': 'N-terminal Pro-B-type Natriuretic Peptide Level (Phase I)', 'timeFrame': 'Week 7', 'description': 'To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo'}, {'measure': 'N-terminal Pro-B-type Natriuretic Peptide Level (Phase II)', 'timeFrame': 'Week 13', 'description': 'To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo'}, {'measure': 'Improvement in Daily Activity - Hours Active Per Day (Phase I)', 'timeFrame': '5-6 weeks', 'description': 'To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug'}, {'measure': 'Improvement in Daily Activity - Hours Active Per Day (Phase II)', 'timeFrame': '11-12 weeks', 'description': 'To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug'}, {'measure': 'Improvement in Daily Activity - Slope of Daily Average (Phase I)', 'timeFrame': '3-6 weeks', 'description': 'To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.'}, {'measure': 'Improvement in Daily Activity - Slope of Daily Average (Phase II)', 'timeFrame': '9-12 weeks', 'description': 'To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.'}, {'measure': 'Improvement in Daily Activity - Area Under the Curve (Phase I)', 'timeFrame': '3-6 weeks', 'description': 'To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7\\*average acceleromtery units/day during 30 mg) + (7\\*average acceleromtery units/day during 60 mg) + (14\\*average acceleromtery units/day during 120 mg))/28'}, {'measure': 'Improvement in Daily Activity - Area Under the Curve (Phase II)', 'timeFrame': '9-12 weeks', 'description': 'To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7\\*average acceleromtery units/day during 30 mg) + (7\\*average acceleromtery units/day during 60 mg) + (14\\*average acceleromtery units/day during 120 mg))/28'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'Preserved Ejection Fraction'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '32150314', 'type': 'DERIVED', 'citation': 'Reddy YNV, Rikhi A, Obokata M, Shah SJ, Lewis GD, AbouEzzedine OF, Dunlay S, McNulty S, Chakraborty H, Stevenson LW, Redfield MM, Borlaug BA. Quality of life in heart failure with preserved ejection fraction: importance of obesity, functional capacity, and physical inactivity. Eur J Heart Fail. 2020 Jun;22(6):1009-1018. doi: 10.1002/ejhf.1788. Epub 2020 Mar 9.'}, {'pmid': '28588021', 'type': 'DERIVED', 'citation': 'Snipelisky D, Kelly J, Levine JA, Koepp GA, Anstrom KJ, McNulty SE, Zakeri R, Felker GM, Hernandez AF, Braunwald E, Redfield MM. Accelerometer-Measured Daily Activity in Heart Failure With Preserved Ejection Fraction: Clinical Correlates and Association With Standard Heart Failure Severity Indices. Circ Heart Fail. 2017 Jun;10(6):e003878. doi: 10.1161/CIRCHEARTFAILURE.117.003878.'}, {'pmid': '26549714', 'type': 'DERIVED', 'citation': 'Redfield MM, Anstrom KJ, Levine JA, Koepp GA, Borlaug BA, Chen HH, LeWinter MM, Joseph SM, Shah SJ, Semigran MJ, Felker GM, Cole RT, Reeves GR, Tedford RJ, Tang WH, McNulty SE, Velazquez EJ, Shah MR, Braunwald E; NHLBI Heart Failure Clinical Research Network. Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2015 Dec 10;373(24):2314-24. doi: 10.1056/NEJMoa1510774. Epub 2015 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'A randomized, double-blinded, placebo-controlled crossover study to assess effect of isosorbide mononitrate with dose up-titration on activity tolerance as assessed by (hip-worn, tri-axial) accelerometry.', 'detailedDescription': 'To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 50 years\n2. Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea\n3. Ejection fraction (EF) ≥ 50% as determined on imaging study within 12 months of enrollment with no change in clinical status suggesting potential for deterioration in systolic function\n4. Stable medical therapy for 30 days as defined by:\n\n * No addition or removal of ACE, Angiotensin receptor blockers (ARBs), beta-blockers, calcium channel blockers (CCBs) or aldosterone antagonists\n * No change in dosage of ACE, ARBs, beta-blockers,CCBs or aldosterone antagonists of more than 100%\n5. One of the following within the last 12 months\n\n * Previous hospitalization for heart failure (HF) with radiographic evidence of pulmonary congestion (pulmonary venous hypertension, vascular congestion, interstitial edema, pleural effusion) or\n * Catheterization documented elevated filling pressures at rest (LVEDP≥15 or PCWP≥20) or with exercise (PCWP≥25) or\n * Elevated NT-proBNP (\\> 400 pg/ml) or BNP (\\> 200 pg/ml) or\n * Echo evidence of diastolic dysfunction / elevated filling pressures (at least two) E/A \\> 1.5 + decrease in E/A of \\> 0.5 with valsalva Deceleration time ≤ 140 ms Pulmonary vein velocity in systole \\< diastole (PVs\\<PVd)sinus rhythm) E/e'≥15 Left atrial enlargement (≥ moderate) Pulmonary artery systolic pressure \\> 40 mmHg Evidence of left ventricular hypertrophy\n * LV mass/BSA ≥ 96 (♀) or ≥ 116 (♂) g/m2\n * Relative wall thickness ≥ 0.43 (♂ or ♀) \\[(IVS+PW)/LVEDD\\]\n * Posterior wall thickness ≥ 0.9 (♀) or 1.0 (♂) cm\n6. No chronic nitrate therapy or infrequent (≤ 1x week) use of intermittent sublingual nitroglycerin within last 3 months\n7. Ambulatory (not wheelchair / scooter / walker / cane dependent)\n8. HF is the primary factor limiting activity as indicated by answering # 2 to the following question:\n\nMy ability to be active is most limited by:\n\n1. Joint, foot, leg, hip or back pain\n2. Shortness of breath and/or fatigue and/or chest pain\n3. Unsteadiness or dizziness\n4. Lifestyle, weather, or I just don't like to be active\n\n9\\. Body size allows wearing of the accelerometer belt as confirmed by ability to comfortably fasten the test belt provided for the screening process (belt designed to fit persons with BMI 20-40 Kg/m2 but belt may fit some persons outside this range)\n\n10\\. Willingness to wear the accelerometer belt for the duration of the trial 11. Willingness to provide informed consent\n\nExclusion Criteria:\n\n1. Recent (\\< 3 months) hospitalization for HF\n2. Hemoglobin \\< 8.0 g/dl\n3. Glomerular filtration rate \\< 20 ml/min/1.73 m2 on most recent clinical laboratories\n4. SBP \\< 110 mmHg or \\> 180 mmHg at consent\n5. Diastolic blood pressure \\< 40 mmHg or \\> 100 mmHg at consent\n6. Resting HR \\> 110 bpm at consent\n7. Previous adverse reaction to nitrates necessitating withdrawal of therapy\n8. Chronic therapy with phosphodiesterase type-5 inhibitors (intermittent use of phosphodiesterase type-5 inhibitors for erectile dysfunction is allowable if the patient is willing to hold for the duration of the trial)\n9. Regularly (\\> 1x per week) swims or does water aerobics\n10. Significant COPD thought to contribute to dyspnea\n11. Ischemia thought to contribute to dyspnea\n12. Documentation of previous EF \\< 50%\n13. Acute coronary syndrome within 3 months defined by electrocardiographic changes and biomarkers of myocardial necrosis (e.g. troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent)\n14. Percutaneous coronary intervention, coronary artery bypass grafting or new biventricular pacing within past 3 months\n15. Primary hypertrophic cardiomyopathy\n16. Infiltrative cardiomyopathy (amyloid)\n17. Constrictive pericarditis or tamponade\n18. Active myocarditis\n19. Complex congenital heart disease\n20. Active collagen vascular disease\n21. More than mild aortic or mitral stenosis\n22. Intrinsic (prolapse, rheumatic) valve disease with moderate to severe or severe mitral, tricuspid or aortic regurgitation\n23. Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR \\> 1.7 in the absence of anticoagulation treatment\n24. Terminal illness (other than HF) with expected survival of less than 1 year\n25. Enrollment or planned enrollment in another therapeutic clinical trial in the next 3 months\n26. Inability to comply with planned study procedures\n27. Pregnant women"}, 'identificationModule': {'nctId': 'NCT02053493', 'acronym': 'NEAT-HFpeF', 'briefTitle': "Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction", 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': "Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction", 'orgStudyIdInfo': {'id': 'Pro00050042'}, 'secondaryIdInfos': [{'id': '4U10HL084904-10', 'link': 'https://reporter.nih.gov/quickSearch/4U10HL084904-10', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)', 'interventionNames': ['Drug: Isosorbide Mononitrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Isosorbide Mononitate Placebo', 'description': 'Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Isosorbide Mononitrate', 'type': 'DRUG', 'otherNames': ['Imdur, ISMO, Monoket'], 'description': 'Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN', 'armGroupLabels': ['Isosorbide Mononitrate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dispense phase 1 study drug:\n\nWeeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo\n\nDispense phase-2 study drug:\n\nWeeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo', 'armGroupLabels': ['Isosorbide Mononitate Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02132', 'city': 'West Roxbury', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston V.A. Healthcare System', 'geoPoint': {'lat': 42.27926, 'lon': -71.1495}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Metro Health System', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '17604', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lancaster General Hospital', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Medical College', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E Debakey VA Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospitals and Clinics', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84148', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'V.A. Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'The University of Vermont - Fletcher Allen Health Care', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Kevin Anstrom, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Clinical Research Institute'}, {'name': 'Eugene Braunwald, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Harvard University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'After the study results have been published, site-specific participant data will be shared with sites upon request. Sites are expected to follow their specific institutional policies regarding sharing results with their participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adrian Hernandez', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'University of Vermont', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, DUMC; Director, Health Services and Outcomes Research, DCRI', 'investigatorFullName': 'Adrian Hernandez', 'investigatorAffiliation': 'Duke University'}}}}