Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT01377103
Status:
WITHDRAWN
Last Update Posted:
2017-07-19
First Post:
2011-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testosterone Therapy in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-14', 'studyFirstSubmitDate': '2011-05-18', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'heart failure outcomes', 'timeFrame': '16 months', 'description': 'rehospitalization rates, mortality, New York Heart Association class and symptomatolgy'}, {'measure': 'depression and mood', 'timeFrame': '16 months', 'description': 'Beck Depression Inventory: a 21-question multiple-choice self-report inventory for measuring the severity of depression'}, {'measure': 'quality of life', 'timeFrame': '16 months', 'description': 'Minnesota Living with Heart Failure Questionnaire'}], 'secondaryOutcomes': [{'measure': 'overall satisfaction', 'timeFrame': '16 months', 'description': 'Minnesota Living with Heart Failure Questionnaire'}, {'measure': 'compliance', 'timeFrame': '16 months', 'description': 'documentation of study medication usage'}, {'measure': 'markers for heart failure', 'timeFrame': '16 months', 'description': 'natriuretic peptide, creatinine, and left ventricular ejection fraction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart failure', 'hypogonadism', 'testosterone'], 'conditions': ['Heart Failure', 'Hypogonadism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether benefits of topical testosterone on symptoms and function of male HF patients, and its effects on rehospitalization rates and quality of life.', 'detailedDescription': 'Recent evidence has started to emerge regarding the benefits of testosterone in the heart failure (HF) population. Firstly, testosterone directly augments vascular resistance by causing vasodilation of peripheral vessels which can decrease afterload and improve cardiac output. In addition, testosterone causes coronary artery vasodilation and improves cardiac ischemic threshold based on subjective and objective measures. Clinically, several studies have pointed out the potential benefits patients with HF can derive from testosterone therapy. Measures of cardiopulmonary function tests, six minute walk test, incremental shuttle walk test and baroreflex sensitivity, all of which have prognostic implications for patients with HF, show improvement with the addition of testosterone therapy to traditional-medical management. In addition to these objective measurements, mood, NYHA functional class and muscle strength are all improved by treatment with testosterone supplementation. While past studies have used functional and prognostic measures as outcomes, other issues common in patients with HF, such as sexual dysfunction and repeat hospitalizations, have the potential for improvement with testosterone therapy\n\nThe majority of studies performed in the past have utilized intramuscular or transdermal patch delivery systems of testosterone as a means for supplementation. These methods have inherent issues as a means of treatment as patients often times do not have the means to receive intramuscular injections and patches have a high level of skin reactions making compliance difficult. Topical administration of testosterone gel may prove to be a more efficacious method for testosterone supplementation with a lower side effect profile and adequate absorption. It has been used with success by the general public for treatment of hypogonadal symptoms, but has not been studied in the HF population. With the emergence of studies showing promising benefits of testosterone supplementation in the HF population, the ease of topical administration for this population would provide benefits to millions suffering from HF.\n\nThe investigators study aims to find the benefits of topical testosterone on symptoms and function of HF patients, and its effects on rehospitalization rates and quality of life.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '36 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* NYHA class II-IV Heart Failure\n* age \\> 35 \\< 80\n* total testosterone level of \\<5 ng/ml\n\nExclusion Criteria:\n\n* elevated prostate specific antigen\n* elevated total or free testosterone level\n* prostate cancer or evidence of symptomatic prostatism\n* untreated prolactinemia or history of breast cancer'}, 'identificationModule': {'nctId': 'NCT01377103', 'briefTitle': 'Testosterone Therapy in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Cardiovascular and Functional Effects of Testosterone Therapy for Hypogonadal Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'TT-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Gel', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Testosterone Supplementation', 'description': 'Testosterone Gel', 'interventionNames': ['Drug: testerone gel']}], 'interventions': [{'name': 'testerone gel', 'type': 'DRUG', 'otherNames': ['AndroGel(R)'], 'description': '5g daily for 4 weeks then 7.5 or 10g daily for 8 weeks; transdermal testosterone gel', 'armGroupLabels': ['Testosterone Supplementation']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ernst Schwarz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Affiliate, Cedars-Sinai Heart Institute', 'investigatorFullName': 'Ernst Schwarz, MD, PhD', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}