Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT02598505
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2015-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C510790', 'term': 'indacaterol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-22', 'studyFirstSubmitDate': '2015-10-22', 'studyFirstSubmitQcDate': '2015-11-04', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of change in lung diffusion of carbon monoxide (CO).', 'timeFrame': 'day 0, 60, 74, 134', 'description': 'comparison of change in lung diffusion of carbon monoxide after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.'}, {'measure': 'measurement of change in membrane diffusion (Dm)', 'timeFrame': 'day 0, 60, 74, 134', 'description': 'comparison of change in mambrane diffusion (Dm) after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.'}, {'measure': 'measurement of change in capillary volume (Vc)', 'timeFrame': 'day 0, 60, 74, 134', 'description': 'comparison of change in Vc after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.'}, {'measure': 'measurement of change in lung diffusion of NO (Nitric Oxide)', 'timeFrame': 'day 0, 60, 74, 134', 'description': 'Measurement of change in lung diffusion of nitric oxide after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are:\n\n1. To confirm safety of Indacaterol in stable Heart Failure.\n2. To determine whether beta 2 alveolar receptor stimulation by Indacaterol is able to ameliorate lung diffusion in heart Failure patients treated with beta blockers.\n3. To compare the effects of Indacaterol in patients treated with a non-selective beta blocker (Carvedilol) and a beta 1-selective beta blocker (Bisoprolol).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female adults aged ≥ 18 years who have signed an Informed Consent Form.\n* Patients with light chronic obstructive pulmonary disease never treated with bronchodilator drugs\n* Co-operative patients\n* Patients with a clinical diagnosis of chronic heart failure (HF)\n* chronic myeloproliferative disorder with ejection fraction \\< 40% with B Blockers therapy since at least 2 months. Optimized and individually tailored drug treatment including B blocker (Carvedilol or bisoprolol)\n* Capability of performing Cardiopulmonary Exercise Test and lung diffusion test\n\nExclusion Criteria:\n\nHistory or clinical documentation of:\n\n* pulmonary embolism\n* primary valvular heart disease\n* pericardial disease\n* severe obstructive lung disease\n* significant peripheral vascular disease\n* exercise-induced angina, st changes, or severe arrhythmias.\n* Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or HbA1c \\> 8.0 % of total hemoglobin measured.\n* Use of bronchodilators.\n* Patients with a history (or family history) of long QT syndrome or whose corrected QT interval interval (Fridericia) measured at Visit 2 is prolonged: \\>450 ms (males) or \\>470 ms (females) as assessed by the central electrocardiogram (ECG) interpretation.'}, 'identificationModule': {'nctId': 'NCT02598505', 'briefTitle': 'Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation', 'organization': {'class': 'OTHER', 'fullName': 'Centro Cardiologico Monzino'}, 'officialTitle': 'Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation', 'orgStudyIdInfo': {'id': 'R111/14 CCM 89'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indacaterol', 'description': 'Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol', 'interventionNames': ['Drug: Indacaterol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Indacaterol', 'type': 'DRUG', 'armGroupLabels': ['Indacaterol']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20138', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Centro Cardiologico Monzino', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Piergiuseppe Agostoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Cardiologico Monzino'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Cardiologico Monzino', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Piergiuseppe Agostoni', 'investigatorAffiliation': 'Centro Cardiologico Monzino'}}}}