Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:58 PM
Study NCT ID:
NCT01971593
Status:
TERMINATED
Last Update Posted:
2018-05-04
First Post:
2013-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013771', 'term': 'Tetralogy of Fallot'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077545', 'term': 'Eplerenone'}], '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': 'acedars97@gmail.com', 'phone': '3149224788', 'title': 'Ari Cedars', 'organization': 'UT Southwestern'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Incomplete study enrollment led to inadequate power to derive reliable conclusions.'}}, 'adverseEventsModule': {'timeFrame': 'During 12 months while on eplerenone', 'description': 'Adverse event data only collected during the eplerenone period', 'eventGroups': [{'id': 'EG000', 'title': 'Eplerenone Period', 'description': 'Change from baseline at time of drug initiation', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 6, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Leg cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Procollagen N-terminal Peptide 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Group', 'description': 'Change from baseline at time of drug initiation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '45.1', 'spread': '15.4', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '48.9', 'spread': '20.3', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '42.7', 'spread': '12.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months from eplerenone administration', 'unitOfMeasure': 'ug/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome analyzed only during the eplerenone period as specified in the protocol'}, {'type': 'PRIMARY', 'title': 'Procollagen III N-Terminal Peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Group', 'description': 'Change from baseline at time of drug initiation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months from eplerenone administration', 'unitOfMeasure': 'ug/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome analyzed only during the eplerenone period as specified in the protocol'}, {'type': 'PRIMARY', 'title': 'Galectin 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Group', 'description': 'Change from baseline at time of drug initiation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.0', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '11.6', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '11.2', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months from eplerenone administration', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome analyzed only during the eplerenone period as specified in the protocol'}, {'type': 'SECONDARY', 'title': '6 Minute Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Group', 'description': 'Change from baseline at time of drug initiation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1629', 'spread': '261', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '1630', 'spread': '250', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '1680.2', 'spread': '255', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months, 12 months from eplerenone administration', 'unitOfMeasure': 'Feet', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome analyzed only during the eplerenone period as specified in the protocol'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Group', 'description': 'Change from baseline at time of drug initiation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '95'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '97.5'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '95'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months, 12 months from eplerenone administration', 'description': 'Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome analyzed only during the eplerenone period as specified in the protocol'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Group', 'description': 'Change from baseline at time of drug initiation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months, 12 months from eplerenone administration', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome analyzed only during the eplerenone period as specified in the protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eplerenone After Drug Free Period', 'description': 'Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period\n\nEplerenone'}, {'id': 'FG001', 'title': 'Eplerenone Before Drug Free Period', 'description': 'Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period\n\nEplerenone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Study Group', 'description': 'Crossover study, all patients pooled for baseline analysis'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tetralogy of Fallot', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Patients with Transposition of the Great Vessels with a Systemic Right Ventricle (RV)', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'Investigator left institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2013-10-23', 'resultsFirstSubmitDate': '2018-01-25', 'studyFirstSubmitQcDate': '2013-10-23', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-03', 'studyFirstPostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum Creatinine', 'timeFrame': 'Baseline, 6 months, 12 months from eplerenone administration'}], 'primaryOutcomes': [{'measure': 'Procollagen N-terminal Peptide 1', 'timeFrame': 'Baseline, 6 months and 12 months from eplerenone administration'}, {'measure': 'Procollagen III N-Terminal Peptide', 'timeFrame': 'Baseline, 6 months and 12 months from eplerenone administration'}, {'measure': 'Galectin 3', 'timeFrame': 'Baseline, 6 months and 12 months from eplerenone administration'}], 'secondaryOutcomes': [{'measure': '6 Minute Walk', 'timeFrame': 'Baseline, 6 months, 12 months from eplerenone administration'}, {'measure': 'Quality of Life', 'timeFrame': 'Baseline, 6 months, 12 months from eplerenone administration', 'description': 'Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Tetralogy of Fallot', 'Transposition of the Great Vessels With an Arterial Switch', 'Single Ventricle With a Fontan Palliation']}, 'descriptionModule': {'briefSummary': 'Hypothesis:\n\nBy blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias decreased through decreases in myocardial fibrosis.\n\nHalf of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6 minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months without therapy, after 6 months on therapy, then finally after 12 months of eplerenone therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12 months on therapy. Patients will be randomly assigned to drug free period up front versus at the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established diagnosis of tetralogy of Fallot, transposition of the great vessels with a systemic right ventricle, or Fontan type palliation\n* Patient followed regularly at Washington University-affiliated institution\n* If female, willing to use 2 forms of contraception including one barrier method during protocol\n\nExclusion Criteria:\n\n* GFR \\<30 ml/min\n* Potassium \\>5.0 mmol/L\n* Unable or unwilling to comply with study protocol\n* Use of potassium sparing diuretics\n* Use of an aldosterone blocker currently or previously\n* Known intolerance of eplerenone or aldosterone blockade\n* Pregnant, breastfeeding, or actively trying to get pregnant'}, 'identificationModule': {'nctId': 'NCT01971593', 'briefTitle': 'The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease', 'orgStudyIdInfo': {'id': 'WI170964'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Eplerenone after drug free period', 'description': 'Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period', 'interventionNames': ['Drug: Eplerenone']}, {'type': 'OTHER', 'label': 'Eplerenone before drug free period', 'description': 'Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period', 'interventionNames': ['Drug: Eplerenone']}], 'interventions': [{'name': 'Eplerenone', 'type': 'DRUG', 'otherNames': ['Inspra'], 'armGroupLabels': ['Eplerenone after drug free period', 'Eplerenone before drug free period']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Ari Cedars', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}