Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 8:12 AM
Study NCT ID:
NCT04495712
Status:
COMPLETED
Last Update Posted:
2020-10-09
First Post:
2020-07-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antiarrhythmic Effects of Spironolactone in Patients With ICDs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014693', 'term': 'Ventricular Fibrillation'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}, 'interventionBrowseModule': {'meshes': [{'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': 'merritt.raitt@va.gov', 'phone': '503-220-8262', 'title': 'Merritt Raitt MD', 'phoneExt': '57571', 'organization': 'VA Portland Health Care System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A limitation of this study was its small sample size. If a 35% relative risk reduction in the primary end point were assumed, the sample size of this trial would have given it 76% power with a type I error rate of 0.05.'}}, 'adverseEventsModule': {'timeFrame': 'life of the study mean 35 months', 'eventGroups': [{'id': 'EG000', 'title': 'Spironolactone', 'description': 'Patients randomized to active therapy with spironolactone\n\nspironolactone: aldosterone blocker', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 44, 'seriousNumAtRisk': 44, 'deathsNumAffected': 13, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'Placebo', 'description': 'patients randomized to placebo\n\nplacebo: identical in appearance to spironolactone study drug', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 46, 'seriousNumAtRisk': 46, 'deathsNumAffected': 12, 'seriousNumAffected': 37}], 'otherEvents': [{'term': 'Gynecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 33}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prerenal azotemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Any gastrointestinal issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'hospitalization', 'notes': 'hospitalization for any cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Appropriate Implantable Cardioverter Defibrillator (ICD) Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spironolactone', 'description': 'Patients randomized to active therapy with spironolactone\n\nspironolactone: aldosterone blocker'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'patients randomized to placebo\n\nplacebo: identical in appearance to spironolactone study drug'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '37.2'}, {'value': '12.3', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '38.5'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'through study completion, an average of 35 months', 'description': 'Time to first documented ICD therapy for ventricular tachycardia or ventricular fibrillation after randomization', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'all enrolled patients'}, {'type': 'SECONDARY', 'title': 'All Cause Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spironolactone', 'description': 'Patients randomized to active therapy with spironolactone\n\nspironolactone: aldosterone blocker'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'patients randomized to placebo\n\nplacebo: identical in appearance to spironolactone study drug'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 35 months', 'description': 'Number of patients hospitalized for any reason during study follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized patients'}, {'type': 'SECONDARY', 'title': 'Ventricular Refractoriness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spironolactone', 'description': 'Patients randomized to active therapy with spironolactone\n\nspironolactone: aldosterone blocker'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'patients randomized to placebo\n\nplacebo: identical in appearance to spironolactone study drug'}], 'classes': [{'categories': [{'measurements': [{'value': '294.2', 'spread': '40.8', 'groupId': 'OG000'}, {'value': '278.3', 'spread': '24.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'measured 3 months after randomization', 'description': 'The right ventricular effective refractory period (ERP) will be measured at 3 month in patients enrolled at the Portland VA Medical Center by single extra stimuli via their implanted defibrillator. The ERP is defined as the shortest paced beat coupling interval that fails to produce ventricular capture after a baseline stable pacing train.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized at the Portland VA Hospital that consented to testing'}, {'type': 'SECONDARY', 'title': 'Short Form Health Survey Adapted for Veterans (SF36V)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spironolactone', 'description': 'Patients randomized to active therapy with spironolactone\n\nspironolactone: aldosterone blocker'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'patients randomized to placebo\n\nplacebo: identical in appearance to spironolactone study drug'}], 'classes': [{'categories': [{'measurements': [{'value': '54.87', 'spread': '22.50', 'groupId': 'OG000'}, {'value': '63.31', 'spread': '20.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months after enrollment', 'description': 'Short Form Health Survey adapted for veterans (SF36V) is a 36 item questionnaire that measures general physical and mental health \\[17\\]. The SF36V is a reliable and valid questionnaire, containing eight constructs of health status: physical functioning (PF), role limitations due to physical problems (RP), bodily pain (BP), general health perceptions (GH), energy/vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). These eight dimensions can be summarized numerically into two scores, the physical component summary (PCS) and the mental component summary (MCS). Range 0-100 higher score is better Health Related Quality of Life (HRQOL). We are reporting the Mental Component Summary score at 12 months here.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Concerns Assessment (PCA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spironolactone', 'description': 'Patients randomized to active therapy with spironolactone\n\nspironolactone: aldosterone blocker'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'patients randomized to placebo\n\nplacebo: identical in appearance to spironolactone study drug'}], 'classes': [{'categories': [{'measurements': [{'value': '22.15', 'spread': '12.28', 'groupId': 'OG000'}, {'value': '18.42', 'spread': '10.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Patient Concerns Assessment (PCA) is a symptom checklist that measures physical symptoms and fears that are common after ICD implantation. The PCA is a disease-specific instrument for ICD QOL, symptoms, and distress, with a reliability of ( = 0.88). Range 0-44, a higher score reflects more concerns and fears.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spironolactone', 'description': 'Patients randomized to active therapy with spironolactone\n\nspironolactone: aldosterone blocker'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'patients randomized to placebo\n\nplacebo: identical in appearance to spironolactone study drug'}], 'classes': [{'categories': [{'measurements': [{'value': '57.35', 'spread': '28.59', 'groupId': 'OG000'}, {'value': '68.67', 'spread': '22.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 35 months', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item reliable and valid questionnaire, which evaluates HRQOL in heart failure. It quantifies, in a disease-specific fashion, physical limitations, symptoms, quality of life, social interference and self-efficacy. KCCQ provides the calculation of 2 main scores, the overall score and the clinical summary score, which includes functional status, social limitation and quality of life domains scores. Range 0-100, higher scores represent higher HRQOL.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spironolactone', 'description': 'Patients randomized to active therapy with spironolactone\n\nspironolactone: aldosterone blocker'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'patients randomized to placebo\n\nplacebo: identical in appearance to spironolactone study drug'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Spironolactone', 'description': 'Patients randomized to active therapy with spironolactone\n\nspironolactone: aldosterone blocker'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'patients randomized to placebo\n\nplacebo: identical in appearance to spironolactone study drug'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66.6', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '66.5', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '66.5', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], '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': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All participants, providers, investigators, and outcome assessors were blinded to treatment assignment. The pharmacy maintained a key to randomization that was not broken until the study was completed and all outcomes had been assessed.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This was a prospective, double-blind, randomized trial that assigned patients to receive either spironolactone 25 mg/day or a placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2008-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-07', 'studyFirstSubmitDate': '2020-07-28', 'resultsFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-07-28', 'lastUpdatePostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-19', 'studyFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Appropriate Implantable Cardioverter Defibrillator (ICD) Therapy', 'timeFrame': 'through study completion, an average of 35 months', 'description': 'Time to first documented ICD therapy for ventricular tachycardia or ventricular fibrillation after randomization'}], 'secondaryOutcomes': [{'measure': 'All Cause Hospitalization', 'timeFrame': 'through study completion, an average of 35 months', 'description': 'Number of patients hospitalized for any reason during study follow-up.'}, {'measure': 'Ventricular Refractoriness', 'timeFrame': 'measured 3 months after randomization', 'description': 'The right ventricular effective refractory period (ERP) will be measured at 3 month in patients enrolled at the Portland VA Medical Center by single extra stimuli via their implanted defibrillator. The ERP is defined as the shortest paced beat coupling interval that fails to produce ventricular capture after a baseline stable pacing train.'}, {'measure': 'Short Form Health Survey Adapted for Veterans (SF36V)', 'timeFrame': '12 months after enrollment', 'description': 'Short Form Health Survey adapted for veterans (SF36V) is a 36 item questionnaire that measures general physical and mental health \\[17\\]. The SF36V is a reliable and valid questionnaire, containing eight constructs of health status: physical functioning (PF), role limitations due to physical problems (RP), bodily pain (BP), general health perceptions (GH), energy/vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). These eight dimensions can be summarized numerically into two scores, the physical component summary (PCS) and the mental component summary (MCS). Range 0-100 higher score is better Health Related Quality of Life (HRQOL). We are reporting the Mental Component Summary score at 12 months here.'}, {'measure': 'Patient Concerns Assessment (PCA)', 'timeFrame': '12 months', 'description': 'Patient Concerns Assessment (PCA) is a symptom checklist that measures physical symptoms and fears that are common after ICD implantation. The PCA is a disease-specific instrument for ICD QOL, symptoms, and distress, with a reliability of ( = 0.88). Range 0-44, a higher score reflects more concerns and fears.'}, {'measure': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': 'through study completion, an average of 35 months', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item reliable and valid questionnaire, which evaluates HRQOL in heart failure. It quantifies, in a disease-specific fashion, physical limitations, symptoms, quality of life, social interference and self-efficacy. KCCQ provides the calculation of 2 main scores, the overall score and the clinical summary score, which includes functional status, social limitation and quality of life domains scores. Range 0-100, higher scores represent higher HRQOL.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti-Arrhythmia Agents', 'Ventricular Fibrillation', 'Ventricular Tachycardia', 'Defibrillators, Implantable'], 'conditions': ['Ventricular Arrhythmias']}, 'referencesModule': {'references': [{'pmid': '22773022', 'type': 'RESULT', 'citation': 'Zarraga IG, Dougherty CM, MacMurdy KS, Raitt MH. The effect of spironolactone on ventricular tachyarrhythmias in patients with implantable cardioverter-defibrillators. Circ Arrhythm Electrophysiol. 2012 Aug 1;5(4):739-47. doi: 10.1161/CIRCEP.112.970566. Epub 2012 Jul 7.'}, {'pmid': '34362264', 'type': 'DERIVED', 'citation': 'Liberato ACS, Raitt MH, Zarraga IGE, MacMurdy KS, Dougherty CM. Health-Related Quality of Life in the Spironolactone to Reduce ICD Therapy (SPIRIT) Trial. Clin Nurs Res. 2022 May;31(4):588-597. doi: 10.1177/10547738211036817. Epub 2021 Aug 6.'}]}, 'descriptionModule': {'briefSummary': 'This study will test whether spironolactone, an approved drug for among other things hypertension, will reduce the risk of severe arrhythmias in patients with implanted defibrillators. Half the patients in the study will get spironolactone and half will get a placebo. Neither the patients or their providers will know if they are getting spironolactone or placebo.', 'detailedDescription': 'Objectives: This study is designed to determine whether spironolactone at a dose of 25 mg per day in patients with implanted cardioverter defibrillators (ICD) will 1) Reduce the incidence of ventricular tachycardia (VT) and ventricular fibrillation (VF), 2) Improve health related quality of life, 3) Reduce the need for hospitalization, and 4) Change ventricular refractoriness.\n\nPlan: The study was a randomized double blind placebo controlled multi-center trial. Patients were randomized to either 25 mg per day of spironolactone or placebo and followed for 2 years each. The primary endpoint is time to the first episode of VT/VF. Secondary endpoints will include changes in health related quality of life, frequency of hospitalization, and in a subset of patients the effect of spironolactone on the ventricular effective refractory period measured through the ICD 3 months after starting the study medication. All data analyses will be conducted on intent to treat basis.\n\nMethods: Patients were recruited at the Portland VA ICD clinics, the Seattle VA ICD clinics, Oregon Health and Sciences University ICD clinics and the Little Rock, Arkansas VA ICD clinics. Randomization and drug preparation were done by the Portland VA Medical Center research pharmacy. For safety purposes serum potassium will be measured at 1, 2, 3, 6, 12, 18, and 24 months. Patients will undergo ICD interrogation to document the occurrence of ICD therapy for VT or VF and will be screened for potential drug side effects every 3 months during the study. Health related quality of life will be measured at baseline, 3, 6, 12, 18, and 24 months using Short Form Health Survey adapted for veterans (SF36V) Veterans Health Study Version, the Patients Concerns Assessment, and the Kansas City Cardiomyopathy Questionnaire. Hospitalizations will be tracked throughout the study. In the subset of patient enrolled at the Portland VA the ventricular effective refractory period will be measured via single extra stimuli pacing through the ICD at 3 months after randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients were considered eligible for enrollment only if they had received\n\n* an ICD therapy, either a shock or antitachycardia pacing (ATP),\n* VT/VF in the previous 2 years or\n* received an ICD for secondary prevention of sustained VT/VF in the previous 6 months.\n\nExclusion Criteria:\n\n-Important exclusion criteria were\n\n* an indication for spironolactone based on the RALES trial (EF of \\<35% and -New York Heart Association (NYHA) class III or IV),\n* unstable angina,\n* primary hepatic failure,\n* known intolerance to spironolactone,\n* a serum creatinine concentration of \\>2.5 mg/dL,\n* a serum potassium concentration of \\>5.0 mmol/L, and\n* a life expectancy of \\<2 years.'}, 'identificationModule': {'nctId': 'NCT04495712', 'acronym': 'SPIRIT', 'briefTitle': 'Antiarrhythmic Effects of Spironolactone in Patients With ICDs', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Antiarrhythmic Effects of Spironolactone in Patients With ICDs', 'orgStudyIdInfo': {'id': 'ICDAD-1'}, 'secondaryIdInfos': [{'id': 'VA 02-2704', 'type': 'OTHER_GRANT', 'domain': 'Department of Defene and VA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spironolactone', 'description': 'Patients randomized to active therapy with spironolactone', 'interventionNames': ['Drug: spironolactone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'patients randomized to placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'spironolactone', 'type': 'DRUG', 'otherNames': ['Aldactone'], 'description': 'aldosterone blocker', 'armGroupLabels': ['Spironolactone']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'identical in appearance to spironolactone study drug', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'VA Portland Health Care System, Portland, OR', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Merritt Raitt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Portland Health Care System, Portland, OR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patients did not give permission for data sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}