Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-29 @ 9:56 PM
Study NCT ID:
NCT05008432
Status:
COMPLETED
Last Update Posted:
2024-08-28
First Post:
2021-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Apnea in Heart Failure With Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-08-10', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the impact of intervention with CPAP therapy on quality of life as assessed by Kansas City Cardiomyopathy Questionnaire scores (Scale 0-100) in patients with Obstructive Sleep Apnea at Baseline', 'timeFrame': '6 months', 'description': 'Quality of life will be assessed by Kansas City Cardiomyopathy Questionnaire (Scale 0-100)'}], 'secondaryOutcomes': [{'measure': 'Determine the impact of intervention with CPAP therapy on average daily accelerometry units (scale -1000 to 10000 units) by wearable accelerometers in patients with Obstructive Sleep Apnea at Baseline', 'timeFrame': '6 months', 'description': 'Average daily accelerometry units by wearable accelerometers (scale -1000 to 10000 units)'}, {'measure': 'Determine the impact of intervention with CPAP therapy on hours active per day (number of hours of activity per day range 0-12 hours) by wearable accelerometers in patients with Obstructive Sleep Apnea at Baseline', 'timeFrame': '6 months', 'description': 'Hours of activity per day by wearable accelerometers (number of hours of activity per day range 0-12 hours)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Obstructive Sleep Apnea']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective interventional study to better understand i) the prevalence of Obstructive Sleep Apnea (OSA) in Heart Failure with preserved Ejection Fraction (HFpEF), ii) its hemodynamic correlates, and iii) the impact of intervention with Continuous Positive Airway Pressure (CPAP) on quality of life.', 'detailedDescription': 'This is a prospective non-randomized observational study which will recruit patients with gold standard HFpEF defined by exercise catheterization or following HF hospitalization. The prevalence of OSA will be determined in all HFpEF patients at baseline using home sleep apnea testing and all patients will complete the Mayo Sleep Questionnaire. Patients with known OSA at baseline will also be included only for the baseline assessment to accurately estimate prevalence of OSA in gold standard diagnosed HFpEF. The subset of initially recruited patients with HFpEF who have newly diagnosed OSA will be offered and initiated on CPAP therapy to treat their underlying OSA. Repeat evaluation after 3 months of CPAP therapy for end point assessment with remote accelerometry (2 weeks prior to study completion), ESS and KCCQ, which will all be identical to baseline measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Heart failure patients with preserved ejection fraction.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of HFpEF by catheterization with resting PCWP\\>15 mmHg or exercise PCWP\\>25 mmHg or hospitalization with HFpEF\n* Ambulatory (not wheelchair/scooter dependent)\n* If no known diagnosis of OSA, must not be pacemaker dependent with either atrial pacing or VVI without sinus rhythm\n* If no known diagnosis of OSA, must be able to temporarily hold nitrates or alpha channel blockers for home WatchPAT testing (3 hour washout period)\n\nExclusion Criteria:\n\n* Ejection fraction \\<40%\n* Obstructive hypertrophic cardiomyopathy\n* Constrictive pericarditis or tamponade\n* Active myocarditis\n* Complex congenital heart disease\n* Other valve disease requiring surgical intervention\n* Terminal illness (other than HF) with expected survival of less than 1 year\n* Inability to comply with planned study procedures\n* Pregnancy or breastfeeding mothers'}, 'identificationModule': {'nctId': 'NCT05008432', 'briefTitle': 'Sleep Apnea in Heart Failure With Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Sleep Apnea in Heart Failure With Preserved Ejection Fraction - Exercise Capacity and Impact of Positive Airway Pressure Therapy', 'orgStudyIdInfo': {'id': '21-002139'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HFpEF Patients Diagnosed with Obstructive Sleep Apnea', 'description': 'Right heart cath patients who are diagnosed with HFpEF will undergo a home sleep apnea test (for patients hospitalized with HFpEF, the initial home sleep test will be performed in hospital overnight)', 'interventionNames': ['Diagnostic Test: Home sleep apnea testing']}], 'interventions': [{'name': 'Home sleep apnea testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will be monitored with a WatchPAT device for home based diagnosis of OSA (for patients hospitalized with HFpEF, the sleep test may be performed in the hospital or at home).', 'armGroupLabels': ['HFpEF Patients Diagnosed with Obstructive Sleep Apnea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Yogesh Reddy, M.B.B.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Itamar-Medical, Israel', 'class': 'INDUSTRY'}, {'name': 'Sleep Number Corporation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Yogesh Reddy', 'investigatorAffiliation': 'Mayo Clinic'}}}}