Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT00206232
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novel Treatment for Diastolic Heart Failure in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-01-21', 'releaseDate': '2021-01-04'}], 'estimatedResultsFirstSubmitDate': '2021-01-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D054144', 'term': 'Heart Failure, Diastolic'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-15', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Procollagen peptides, troponin I, tumor necrosis factor alpha, Brain Natriuretic Peptide', 'timeFrame': 'Baseline then 3 and 6 months after randomization'}, {'measure': 'Electrolytes, blood urea nitrogen, creatinine', 'timeFrame': 'Screening and enrollment then 10 days, 4 weeks, 11 weeks, 13 weeks, and 15 weeks after randomization'}, {'measure': 'Quality of Life Questionaire', 'timeFrame': 'Baseline, then 3 and 6 months after randomization'}, {'measure': 'New York Heart Association Classification', 'timeFrame': 'Baseline then 3 and 6 months after randomization'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'From randomization until trial completion at 6 months.'}], 'primaryOutcomes': [{'measure': 'Six minute walk distance', 'timeFrame': 'Baseline, then 3 and 6 months after randomization'}], 'secondaryOutcomes': [{'measure': 'Echocardiography parameters of diastolic function', 'timeFrame': 'Baseline, then 3 and 6 months after randomization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diastolic Heart Failure'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '24905296', 'type': 'DERIVED', 'citation': 'Kurrelmeyer KM, Ashton Y, Xu J, Nagueh SF, Torre-Amione G, Deswal A. Effects of spironolactone treatment in elderly women with heart failure and preserved left ventricular ejection fraction. J Card Fail. 2014 Aug;20(8):560-8. doi: 10.1016/j.cardfail.2014.05.010. Epub 2014 Jun 4.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to collect information about the potential benefit and safety of low dose spironolactone for a patient with diastolic heart failure (DHF) and to determine whether spironolactone can cause the patient's condition to improve.", 'detailedDescription': 'Subjects with diastolic heart failure defined based on clinical symptoms, echocardiography diastology parameters and brain natriuretic peptide level will be randomized in a 1:1 fashion to either placebo or spironolactone 25mg daily for 6 months. They will be assessed over this 6 month period for improvement in exercise capacity, clinical symptoms, echocardiography diastology parameters, and biomarkers specific for heart failure. Safety of spironolactone in this patient population will also be assessed by recording adverse events and following electrolytes, blood urea nitrogen, and creatinine levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who are 18 years of age or older.\n* Women with clinical heart failure for \\> 2 months.\n* Women with left ventricular ejection fraction \\> 50% within 2 months of screening.\n* Women with New York Heart Association class II or III heart failure symptoms.\n* Brain Natriuretic Peptide \\> 62 pg/ml within 2 months of screening.\n* Patient on angiotensin converting enzyme inhibitor or angiotensin receptor blocker therapy for at least 1 month.\n* Blood Pressure no more than 150/95.\n* Patient able to walk more than 50 meters at the time of enrollment.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Current treatment with spironolactone.\n* Severe hepatic impairment.\n* Creatinine \\> 2.5 mg/dl\n* Potassium \\> 5.0 mEq/L\n* Intolerance to spironolactone in the past.\n* Significant valvular heart disease, pericardial disease, or severe chronic lung disease with cor pulmonale.\n* Unstable angina or myocardial infarction within the past 4 weeks.\n* Severe peripheral vascular disease or other physical conditions that would limit the walking distance.\n* Pregnant or lactating females.\n* Participation in any other drug trial within 30 days prior to randomization.\n* Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT00206232', 'briefTitle': 'Novel Treatment for Diastolic Heart Failure in Women', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Novel Treatment for Diastolic Heart Failure in Women', 'orgStudyIdInfo': {'id': 'H - 13988'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spironolactone', 'description': 'Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.', 'interventionNames': ['Drug: Spironolactone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.', 'interventionNames': ['Drug: Spironolactone']}], 'interventions': [{'name': 'Spironolactone', 'type': 'DRUG', 'otherNames': ['Aldactone'], 'description': 'Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.', 'armGroupLabels': ['Placebo', 'Spironolactone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine Heart Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Karla M Kurrelmeyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Karla Kurrelmeyer', 'investigatorAffiliation': 'Baylor College of Medicine'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-01-04', 'type': 'RELEASE'}, {'date': '2021-01-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Karla Kurrelmeyer, MD, Baylor College of Medicine'}}}}