Testosterone Therapy in Heart Failure
- Conditions
- HypogonadismHeart Failure
- Interventions
- Drug: PlaceboDrug: testerone gel
- Registration Number
- NCT01377103
- Lead Sponsor
- Cedars-Sinai Medical Center
- Brief Summary
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.
- Detailed Description
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
The 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.
The 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
- male
- NYHA class II-IV Heart Failure
- age > 35 < 80
- total testosterone level of <5 ng/ml
- elevated prostate specific antigen
- elevated total or free testosterone level
- prostate cancer or evidence of symptomatic prostatism
- untreated prolactinemia or history of breast cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Gel Testosterone Supplementation testerone gel Testosterone Gel
- Primary Outcome Measures
Name Time Method heart failure outcomes 16 months rehospitalization rates, mortality, New York Heart Association class and symptomatolgy
depression and mood 16 months Beck Depression Inventory: a 21-question multiple-choice self-report inventory for measuring the severity of depression
quality of life 16 months Minnesota Living with Heart Failure Questionnaire
- Secondary Outcome Measures
Name Time Method overall satisfaction 16 months Minnesota Living with Heart Failure Questionnaire
compliance 16 months documentation of study medication usage
markers for heart failure 16 months natriuretic peptide, creatinine, and left ventricular ejection fraction.