Testosterone Therapy in Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Cedars-Sinai Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01377103
First received: May 18, 2011
Last updated: July 7, 2011
Last verified: April 2011

May 18, 2011
July 7, 2011
July 2011
October 2012   (final data collection date for primary outcome measure)
  • heart failure outcomes [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    rehospitalization rates, mortality, New York Heart Association class and symptomatolgy
  • depression and mood [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    Beck Depression Inventory: a 21-question multiple-choice self-report inventory for measuring the severity of depression
  • quality of life [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    Minnesota Living with Heart Failure Questionnaire
Same as current
Complete list of historical versions of study NCT01377103 on ClinicalTrials.gov Archive Site
  • overall satisfaction [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    Minnesota Living with Heart Failure Questionnaire
  • compliance [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    documentation of study medication usage
  • markers for heart failure [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    natriuretic peptide, creatinine, and left ventricular ejection fraction.
Same as current
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)
  • Placebo Comparator: Placebo
    Placebo Gel
    Intervention: Drug: testerone gel
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
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
Male
36 Years to 79 Years
No
Contact: Maria Thottan, BS 310- 248-7136 Maria.Thottam@cshs.org
United States
 
NCT01377103
TT-1
No
Ernst Schwarz, MD, PhD, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Abbott
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