Testosterone Therapy in Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01377103
Recruitment Status : Withdrawn
First Posted : June 21, 2011
Last Update Posted : July 19, 2017
Information provided by (Responsible Party):
Ernst Schwarz, MD, PhD, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
Heart Failure Hypogonadism Drug: testerone gel Drug: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Cardiovascular and Functional Effects of Testosterone Therapy for Hypogonadal Patients With Heart Failure
Study Start Date : July 2011
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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 Name: AndroGel(R)

Primary Outcome Measures :
  1. heart failure outcomes [ Time Frame: 16 months ]
    rehospitalization rates, mortality, New York Heart Association class and symptomatolgy

  2. depression and mood [ Time Frame: 16 months ]
    Beck Depression Inventory: a 21-question multiple-choice self-report inventory for measuring the severity of depression

  3. quality of life [ Time Frame: 16 months ]
    Minnesota Living with Heart Failure Questionnaire

Secondary Outcome Measures :
  1. overall satisfaction [ Time Frame: 16 months ]
    Minnesota Living with Heart Failure Questionnaire

  2. compliance [ Time Frame: 16 months ]
    documentation of study medication usage

  3. markers for heart failure [ Time Frame: 16 months ]
    natriuretic peptide, creatinine, and left ventricular ejection fraction.

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01377103

Sponsors and Collaborators
Cedars-Sinai Medical Center
Principal Investigator: Ernst Schwarz, MD, PhD Cedars-Sinai Medical Center

Responsible Party: Ernst Schwarz, MD, PhD, Affiliate, Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center Identifier: NCT01377103     History of Changes
Other Study ID Numbers: TT-1
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: April 2011

Keywords provided by Ernst Schwarz, MD, PhD, Cedars-Sinai Medical Center:
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents