Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-03-27 @ 8:43 AM
Study NCT ID:
NCT00663195
Status:
COMPLETED
Last Update Posted:
2008-04-22
First Post:
2008-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Spironolactone on Matrix Metalloproteinases (MMPs) in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013148', 'term': 'Spironolactone'}, {'id': 'D005665', 'term': 'Furosemide'}], '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'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-18', 'studyFirstSubmitDate': '2008-04-18', 'studyFirstSubmitQcDate': '2008-04-18', 'lastUpdatePostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MMP levels', 'timeFrame': '16 weeks'}]}, 'conditionsModule': {'keywords': ['heart failure', 'fibrosis', 'MMP', 'spironolactone', 'furosemide'], 'conditions': ['Chronic Stable Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of spironolactone on circulating MMP levels and insulin resistance in patients with chronic heart failure.', 'detailedDescription': 'Myocardial fibrosis is observed in failing hearts. MMPs are considered markers of fibrosis. Recently, circulating MMPs can be measured and are elevated in patients with chronic heart failure (CHF). It has been reported that spironolactone improves myocardial fibrosis in CHF animal models. Therefore, the purpose of this study is to evaluate the effects of spironolactone on circulating MMP levels in patients with chronic heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic stable heart failure'}, 'identificationModule': {'nctId': 'NCT00663195', 'briefTitle': 'Effects of Spironolactone on Matrix Metalloproteinases (MMPs) in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Tottori University Hospital'}, 'officialTitle': 'Effects of Spironolactone on Circulating MMPs in Patients With Chronic Heart Failure', 'orgStudyIdInfo': {'id': '#344'}}, 'armsInterventionsModule': {'interventions': [{'name': 'spironolactone + furosemide', 'type': 'DRUG', 'description': 'spironolactone 25mg/day, 16 weeks and furosemide 20mg/day, 16 weeks'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tottori University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kazuhide Ogino', 'oldOrganization': 'Center for Clinical Residency Program, Tottori University Hospital'}}}}