Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-02 @ 11:11 PM
Study NCT ID:
NCT00548912
Status:
WITHDRAWN
Last Update Posted:
2021-12-09
First Post:
2007-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'study ended', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-29', 'studyFirstSubmitDate': '2007-10-23', 'studyFirstSubmitQcDate': '2007-10-23', 'lastUpdatePostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular mass', 'timeFrame': '9 months'}]}, 'conditionsModule': {'keywords': ['Kidney Failure, Chronic', 'Hemodialysis', 'Spironolactone'], 'conditions': ['Kidney Failure, Chronic']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this trial is to assess the effect of spironolactone on heart size and mass', 'detailedDescription': 'Dialysis patients have significant morbidity and mortality associated with left ventricular hypertrophy and cardiac failure. Aldosterone may have an important role in the development of myocardial hypertrophy and remodeling. Animal studies have demonstrated beneficial effects of aldosterone antagonists on myocardial hypertrophy, and human studies have shown significant survival benefit in a non-dialysis population with congestive heart failure. This study evaluates the effect of spironolactone (an aldosterone receptor antagonist) on cardiac hypertrophy in the end-stage renal disease population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hemodialysis patients\n\nExclusion Criteria:\n\n* non compliance\n* hyperkalemia\n* pregnancy\n* expected survival less than 9 months'}, 'identificationModule': {'nctId': 'NCT00548912', 'briefTitle': 'Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease', 'organization': {'class': 'OTHER', 'fullName': 'West Penn Allegheny Health System'}, 'officialTitle': 'Cardiac Magnetic Resonance Imaging in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'RC-3267'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1 group - no arms', 'description': 'no arm just error message', 'interventionNames': ['Drug: Spironolactone']}], 'interventions': [{'name': 'Spironolactone', 'type': 'DRUG', 'armGroupLabels': ['1 group - no arms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Richard Marcus', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Penn Allegheny Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dawnmarie DeFazio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Nephrolgist, Co-Investigator', 'investigatorFullName': 'Dawnmarie DeFazio', 'investigatorAffiliation': 'West Penn Allegheny Health System'}}}}