Testosterone Therapy in Heart Failure

NCT ID: NCT01377103

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-12-31

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.

Conditions

Heart Failure; Hypogonadism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo Gel

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Testosterone Supplementation

Testosterone Gel

Group Type: ACTIVE_COMPARATOR

testerone gel

Intervention Type: DRUG

5g daily for 4 weeks then 7.5 or 10g daily for 8 weeks; transdermal testosterone gel

Interventions

testerone gel

5g daily for 4 weeks then 7.5 or 10g daily for 8 weeks; transdermal testosterone gel

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

AndroGel(R)

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

• Minimum Eligible Age: 36 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ernst Schwarz, MD, PhD

Affiliate, Cedars-Sinai Heart Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ernst Schwarz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Other Identifiers

TT-1

Identifier Type: -

Identifier Source: org_study_id