Testosterone Therapy in Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cardiovascular and Functional Effects of Testosterone Therapy for Hypogonadal Patients With Heart Failure

Conditions
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Heart Failure, Hypogonadism

Intervention / Treatment
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* Drug: testerone gel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male NYHA class II-IV Heart Failure age > 35 < 80 total testosterone level of <5 ng/ml Exclusion Criteria: elevated prostate specific antigen elevated total or free testosterone level prostate cancer or evidence of symptomatic prostatism untreated prolactinemia or history of breast cancer

Ages Eligible for Study
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Minimum Age: 36 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo Gel | Drug: Placebo<br> <br> |
| Active Comparator: Testosterone Supplementation<br>Testosterone Gel | Drug: testerone gel<br>* 5g daily for 4 weeks then 7.5 or 10g daily for 8 weeks; transdermal testosterone gel<br>* Other names: AndroGel(R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart failure outcomes | rehospitalization rates, mortality, New York Heart Association class and symptomatolgy | 16 months | 
| depression and mood | Beck Depression Inventory: a 21-question multiple-choice self-report inventory for measuring the severity of depression | 16 months | 
| quality of life | Minnesota Living with Heart Failure Questionnaire | 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall satisfaction | Minnesota Living with Heart Failure Questionnaire | 16 months | 
| compliance | documentation of study medication usage | 16 months | 
| markers for heart failure | natriuretic peptide, creatinine, and left ventricular ejection fraction. | 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, hypogonadism, testosterone