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Clinical Trials/NCT01377103
NCT01377103WithdrawnNot Applicable

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

Cedars-Sinai Medical Center0 sitesStarted: July 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
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 Comparator

Placebo Gel

Intervention: Placebo (Drug)

Testosterone Supplementation

Active Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ernst Schwarz, MD, PhD

Affiliate, Cedars-Sinai Heart Institute

Cedars-Sinai Medical Center

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