Clinical trial NCT01377103: Testosterone Therapy in Heart Failure
Official title: Cardiovascular and Functional Effects of Testosterone Therapy for Hypogonadal Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Hypogonadism
Keywords: heart failure
hypogonadism
testosterone
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2011-06-21
Enrollment: 0
Sex: MALE
Minimum age (years): 36
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: heart failure outcomes
timeFrame: 16 months
measure: depression and mood
timeFrame: 16 months
measure: quality of life
timeFrame: 16 months
Secondary outcomes:
measure: overall satisfaction
timeFrame: 16 months
measure: compliance
timeFrame: 16 months
measure: markers for heart failure
timeFrame: 16 months
Other outcomes:
Locations:
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ernst Schwarz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: