Testosterone Therapy in Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01377103
• Other study ID #: TT-1
• Status: Withdrawn
• Phase: N/A
• First received: May 18, 2011
• Last updated: July 14, 2017
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2011
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 36 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Hypogonadism

Intervention

Drug:
• testerone gel
5g daily for 4 weeks then 7.5 or 10g daily for 8 weeks; transdermal testosterone gel
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart failure outcomes	rehospitalization rates, mortality, New York Heart Association class and symptomatolgy	16 months
Primary	depression and mood	Beck Depression Inventory: a 21-question multiple-choice self-report inventory for measuring the severity of depression	16 months
Primary	quality of life	Minnesota Living with Heart Failure Questionnaire	16 months
Secondary	overall satisfaction	Minnesota Living with Heart Failure Questionnaire	16 months
Secondary	compliance	documentation of study medication usage	16 months
Secondary	markers for heart failure	natriuretic peptide, creatinine, and left ventricular ejection fraction.	16 months