Testosterone Therapy in Heart Failure
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Endocrine |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 36 - 79 |
| Updated: | 4/2/2016 |
| Start Date: | July 2011 |
| End Date: | December 2012 |
| Contact: | Maria Thottan, BS |
| Email: | Maria.Thottam@cshs.org |
| Phone: | 310- 248-7136 |
Cardiovascular and Functional Effects of Testosterone Therapy for Hypogonadal Patients With Heart Failure
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.
symptoms and function of male HF patients, and its effects on rehospitalization rates and
quality of life.
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.
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.
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
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