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
  Purpose

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 Intervention
Heart Failure
Hypogonadism
Drug: testerone gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Cardiovascular and Functional Effects of Testosterone Therapy for Hypogonadal Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo 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)
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)

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.

  Eligibility

Ages Eligible for Study:   36 Years to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377103

Contacts
Contact: Maria Thottan, BS 310- 248-7136 Maria.Thottam@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center - Center for Advanced Heart Disease Not yet recruiting
Beverly Hills, California, United States, 90211
Contact: Maria Thottam, BS    310-248-7136    Maria.Thottam@cshs.org   
Principal Investigator: Ernst Schwarz, MD, PhD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Abbott
Investigators
Principal Investigator: Ernst Schwarz, MD, PhD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Ernst Schwarz, MD, PhD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01377103     History of Changes
Other Study ID Numbers: TT-1
Study First Received: May 18, 2011
Last Updated: July 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
heart failure
hypogonadism
testosterone

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

ClinicalTrials.gov processed this record on October 23, 2014