NCT02803073
Withdrawn
Phase 2
Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After A Recent Myocardial Infarction.
Overview
- Phase
- Phase 2
- Intervention
- Testosterone
- Conditions
- Hypogonadism
- Sponsor
- Texas Tech University Health Sciences Center
- Locations
- 1
- Primary Endpoint
- Metabolic Equivalent
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to determine the effects of testosterone replacement in hypogonadal men on exercise tolerance and cardiac rehabilitation after an acute myocardial infarction.
Detailed Description
Testosterone deficiency can decrease muscle strength. The researchers will replace testosterone in hypogonadal men undergoing rehabilitation exercises after heart attack.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All men status-post Myocardial Infarction or Non-ST Elevation-Acute Coronary Syndrome within the last 3-8 weeks enrolling in the cardiac rehabilitation program at Mission Fitness-Medical Center Hospital.
- •Baseline free testosterone levels less than age-specific normal values.
- •Males 18 years and older
Exclusion Criteria
- •Prostate Specific Antigen greater than age based, ethnic-specific cut points (see Appendix), history of metastatic prostate cancer or symptoms suggestive of severe Benign Prostatic Enlargement.
- •Current use of testosterone, clomiphene or over the counter testosterone boosters
- •Patients initiating cardiac rehabilitation 8+ weeks after MI or Non-ST Elevation-Acute Coronary Syndrome
- •Congestive heart failure, New York Heart Association class IV
- •Life expectancy less than 1 year,
- •Baseline hematocrit of \>50%
- •Allergic reactions to testosterone or testosterone vehicle (i.e. cotton seed oil, etc.)
- •Physical inability to participate in rehabilitation program (examples: severe claudication, massive obesity, etc.)
- •Participation in any other concurrent clinical trial, use of an investigational agent or therapeutic regimen within 30 days of study
- •Patients formerly diagnosed with obstructive sleep apnea.
Arms & Interventions
Testosterone Replacement
The experimental group will receive 0.5 ml (100 mg) testosterone cypionate Intramuscular injections each week for 11 weeks.
Intervention: Testosterone
Control
Patients in the control group will receive intramuscular normal saline injections.
Intervention: Normal Saline
Outcomes
Primary Outcomes
Metabolic Equivalent
Time Frame: 12 weeks
Secondary Outcomes
- 6 minute walk test(12 weeks)
Study Sites (1)
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