Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT02253394
Status:
TERMINATED
Last Update Posted:
2019-11-15
First Post:
2014-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D007266', 'term': 'Inhibition, Psychological'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C467894', 'term': 'ambrisentan'}, {'id': 'D013148', 'term': 'Spironolactone'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bmaron@bwh.harvard.edu', 'phone': '617-525-4857', 'title': 'Dr. Bradley Maron', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Poor enrollment, study terminated early'}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'AMB + Spiro, Cardiopulmonary Fitness', 'description': 'Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD\n\nAmbrisentan plus Spironolactone: Cardiopulmonary fitness', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Cardiopulmonary Fitness', 'description': 'Placebo mimics spironolactone 50 mg and will be taken QD\n\nAmbrisentan plus Placebo: Placebo is a sugar pill manufactured to resemble spironolactone 50 mg Cardiopulmonary fitness', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of Combination Ambrisentan + Spironolactone on Peak Volume of Oxygen Consumption (pVO2) and Cardiac Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AMB + Spiro, Cardiopulmonary Fitness', 'description': 'Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD'}, {'id': 'OG001', 'title': 'AMB + Placebo First', 'description': 'Ambrisentan 5 or 10 mg QD + placebo'}], 'timeFrame': 'Up to average of 20 min', 'description': 'Study the effect of combination ambrisentan (5-10 mg/d) + spironolactone (50 mg/d) on pVO2 and cardiac output. The pVO2 refers to a measure of general physical fitness measured during exercise.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not reported due to patient privacy considerations owing to low enrollment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AMB + Spiro First, Then Placebo, Cardiopulmonary Fitness', 'description': 'Ambrisentan 5 or 10 mg every day (QD) plus Spironolactone 50 mg QD FIRST, then placebo'}, {'id': 'FG001', 'title': 'AMB + Placebo First, Then Spironolactone', 'description': 'Ambrisentan 5 or 10 mg every day (QD) plus placebo first, then spironolactone 50 mg QD'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'First ambrisentan 5 or 10 mg QD + Spiro 50 mg QD (90 d), then washout (21 d), then +placebo (90 d)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Ambrisentan 5 or 10 mg QD + placebo (90 d) first, then washout (21 d), then +Spiro 50 mg QD (90 d).', 'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AMB + Spiro, Cardiopulmonary Fitness', 'description': 'Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD\n\nAmbrisentan plus Spironolactone: Cardiopulmonary fitness\n\nCross over design'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000', 'lowerLimit': '58', 'upperLimit': '63'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Study-Specific Measure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-24', 'size': 472652, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-28T14:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-13', 'studyFirstSubmitDate': '2014-09-17', 'resultsFirstSubmitDate': '2019-08-28', 'studyFirstSubmitQcDate': '2014-09-27', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-13', 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Combination Ambrisentan + Spironolactone on Peak Volume of Oxygen Consumption (pVO2) and Cardiac Output', 'timeFrame': 'Up to average of 20 min', 'description': 'Study the effect of combination ambrisentan (5-10 mg/d) + spironolactone (50 mg/d) on pVO2 and cardiac output. The pVO2 refers to a measure of general physical fitness measured during exercise.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary Arterial Hypertension (PAH)', 'Ambrisentan', 'Spironolactone', 'Selective Endothelin A (ETA) inhibition', 'Aldosterone antagonism', 'Cardiac output (CO)', 'Right ventricular (RV) function', 'Heart failure', 'Quality of life', 'Pro-inflammatory cytokine', 'Interleukin-6 (IL-6)', 'Troponin-I', 'N-terminal pro-brain natriuretic peptide (NT-BNP)', 'Collagen metabolism', 'N-terminal procollagen type I', 'Collagen III', 'Echocardiography', 'WHO Functional Class', 'Cardiopulmonary Exercise Test with Innocor', 'Peak oxygen consumption (pVO2)', 'Liver function markers (AST/ALT)', 'Renal function markers (creatinine and potassium)'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if spironolactone added to ambrisentan for Pulmonary Arterial Hypertension (PAH) will increase exercise capacity. We also want to find out if spironolactone and ambrisentan effect the cardiac output (amount of blood the heart pumps every minute), right ventricle function and quality of life.', 'detailedDescription': 'A prospective, double blind, placebo-controlled clinical study involving 30 patients with World Health Organization (WHO) Group 1 pulmonary arterial hypertension being treated with ambrisentan randomized to receive placebo or spironolactone (50 mg/d) for 90 days using a cross-over trial design.\n\nEligible participants will be randomized to receive placebo or spironolactone (50 mg/d) for 90 days (Phase I). At the completion of Phase I, participants will undergo repeat end-point assessment followed by a 21-day drug washout period. Then, the 90 day crossover phase of the trial will occur (Phase II), in which participants randomized to placebo in Phase I will be treated with spironolactone (50 mg/d) in Phase II and vice versa. At the conclusion of Phase II, end-point measures are reassessed.\n\nSpironolactone is a diuretic used in treatment of PAH patients. Spironolactone is usually added to medical treatment when doses of Lasix/Torsemide are increased and patients are at risk for hypokalemia.\n\nStudy procedures being done for this research study are the standard procedures performed on all PAH patients when they are in clinic for follow-up except for the Cardiopulmonary Exercise Test (CPET) with Innocor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntarily gives informed consent to participate in the study.\n2. Right heart catheterization demonstrating conventional mean pulmonary artery pressure (mPAP) \\>25, pulmonary vascular resistance (PVR) \\>3.0 Wood Units, pulmonary capillary wedge pressure (PCWP) \\<16 mmHg within two years of enrollment\n3. Subject is 18 years of age or older at Screening.\n4. Diagnosis of symptomatic idiopathic or heritable PAH, PAH associated with Connective Tissue Disease (CTD), PAH associated with repaired/unrepaired congenital systemic-to-pulmonary shunt, Portopulmonary hypertension or PAH associated with HIV infection.\n5. New York Heart Association Functional Class II or III\n6. Stable therapy with ambrisentan 5 or 10 mg every day for \\> 90 days.\n7. Baseline 6-Minute Walk Distance 50-450m\n\nExclusion Criteria:\n\n1. Substantial Primary Lung disease\n\n * forced expiratory volume at one second (FEV-1)/forced vital capacity (FVC) \\<0.6 and FEV-1 \\<70% predicted\n * diffusing capacity of lung for carbon monoxide (DLCO) \\<30% predicted\n * Pulmonary fibrosis\n2. Left ventricular ejection fraction \\< 50%\n3. Pulmonary capillary wedge pressure \\> 16 mm Hg\n4. Aortic valve disease\n5. Ischemic heart disease\n6. Systemic hypotension (SBP \\<90 mm Hg)\n7. Co-existing treatment with other endothelin receptor antagonists or prostacyclin analogues\n8. New York Heart Association Functional Class IV\n9. Chronic thromboembolic pulmonary hypertension\n10. Known or suspected pulmonary veno-occlusive disease\n11. Serum creatinine \\>2.0 mg/dL in women, Serum creatinine \\>2.5 mg/dL in men\n12. Baseline serum potassium \\>5.0 milliequivalent (mEq)/L\n13. Participation in ongoing drug/intervention-based clinical trial\n14. Pregnancy\n15. Unable to provide consent'}, 'identificationModule': {'nctId': 'NCT02253394', 'briefTitle': 'The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study)', 'orgStudyIdInfo': {'id': 'CAPS_PAH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AMB + Spiro, Cardiopulmonary fitness', 'description': 'Ambrisentan 5 or 10 mg every day (QD) Spironolactone 50 mg QD', 'interventionNames': ['Drug: Ambrisentan plus Spironolactone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Cardiopulmonary fitness', 'description': 'Placebo mimics spironolactone 50 mg and will be taken QD', 'interventionNames': ['Drug: Ambrisentan plus Placebo']}], 'interventions': [{'name': 'Ambrisentan plus Spironolactone', 'type': 'DRUG', 'otherNames': ['Letairis plus Aldactone'], 'description': 'Cardiopulmonary fitness', 'armGroupLabels': ['AMB + Spiro, Cardiopulmonary fitness']}, {'name': 'Ambrisentan plus Placebo', 'type': 'DRUG', 'otherNames': ['Letairis'], 'description': 'Placebo is a sugar pill manufactured to resemble spironolactone 50 mg Cardiopulmonary fitness', 'armGroupLabels': ['Placebo Cardiopulmonary fitness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Bradley Maron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor in Medicine', 'investigatorFullName': 'Bradley Maron, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}