Testosterone Therapy in Heart Failure

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.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure; Hypogonadism
• Intervention / Treatment: Drug: Placebo; Drug: testerone gel

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo Gel	Drug: Placebo
Active Comparator: Testosterone Supplementation; Testosterone Gel	Drug: testerone gel; 5g daily for 4 weeks then 7.5 or 10g daily for 8 weeks; transdermal testosterone gel; Other Names: AndroGel(R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart failure outcomes	rehospitalization rates, mortality, New York Heart Association class and symptomatolgy	16 months
depression and mood	Beck Depression Inventory: a 21-question multiple-choice self-report inventory for measuring the severity of depression	16 months
quality of life	Minnesota Living with Heart Failure Questionnaire	16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall satisfaction	Minnesota Living with Heart Failure Questionnaire	16 months
compliance	documentation of study medication usage	16 months
markers for heart failure	natriuretic peptide, creatinine, and left ventricular ejection fraction.	16 months

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: Abbott
• Investigators: Principal Investigator: Ernst Schwarz, MD, PhD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: May 18, 2011
• First Submitted That Met QC Criteria: June 20, 2011
• First Posted (Estimate): June 21, 2011

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 14, 2017
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: hypogonadism; heart failure; testosterone
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Endocrine System Diseases; Gonadal Disorders; Heart Failure; Hypogonadism; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: TT-1