Testosterone Therapy in Heart Failure
|ClinicalTrials.gov Identifier: NCT01377103|
Recruitment Status : Withdrawn
First Posted : June 21, 2011
Last Update Posted : July 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Hypogonadism||Drug: testerone gel Drug: Placebo||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Placebo Comparator: Placebo
Active Comparator: Testosterone Supplementation
Drug: testerone gel
5g daily for 4 weeks then 7.5 or 10g daily for 8 weeks; transdermal testosterone gel
Other Name: AndroGel(R)
- 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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01377103
|Principal Investigator:||Ernst Schwarz, MD, PhD||Cedars-Sinai Medical Center|