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Recruitment Status : Withdrawn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

May 18, 2011
June 21, 2011
July 19, 2017
July 2011
October 2012   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01377103 on Archive Site
  • overall satisfaction [ Time Frame: 16 months ]
    Minnesota Living with Heart Failure Questionnaire
  • compliance [ Time Frame: 16 months ]
    documentation of study medication usage
  • markers for heart failure [ Time Frame: 16 months ]
    natriuretic peptide, creatinine, and left ventricular ejection fraction.
Same as current
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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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Heart Failure
  • Hypogonadism
  • Drug: testerone gel
    5g daily for 4 weeks then 7.5 or 10g daily for 8 weeks; transdermal testosterone gel
    Other Name: AndroGel(R)
  • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo Gel
    Intervention: Drug: Placebo
  • Active Comparator: Testosterone Supplementation
    Testosterone Gel
    Intervention: Drug: testerone gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
36 Years to 79 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
Not Provided
Not Provided
Ernst Schwarz, MD, PhD, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Principal Investigator: Ernst Schwarz, MD, PhD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP