Cardiovascular and Functional Effects of Testosterone Therapy for Hypogonadal Patients With Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Cedars-Sinai Medical Center
- Primary Endpoint
- heart failure outcomes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 36 Years to 79 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Placebo
Placebo Gel
Intervention: Placebo (Drug)
Testosterone Supplementation
Testosterone Gel
Intervention: testerone gel (Drug)
Outcomes
Primary Outcomes
heart failure outcomes
Time Frame: 16 months
rehospitalization rates, mortality, New York Heart Association class and symptomatolgy
depression and mood
Time Frame: 16 months
Beck Depression Inventory: a 21-question multiple-choice self-report inventory for measuring the severity of depression
quality of life
Time Frame: 16 months
Minnesota Living with Heart Failure Questionnaire
Secondary Outcomes
- overall satisfaction(16 months)
- compliance(16 months)
- markers for heart failure(16 months)
Investigators
Ernst Schwarz, MD, PhD
Affiliate, Cedars-Sinai Heart Institute
Cedars-Sinai Medical Center
