Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After a Recent Myocardial Infarction

Study Overview
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Brief Summary
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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
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Testosterone deficiency can decrease muscle strength. The researchers will replace testosterone in hypogonadal men undergoing rehabilitation exercises after heart attack.

Official Title
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Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After A Recent Myocardial Infarction.

Conditions
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Hypogonadism, Acute Myocardial Infarction: Rehabilitation Phase

Intervention / Treatment
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* Drug: Testosterone
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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. Patients using opiate analgesics Patients with aspartate aminotransferase/alanine aminotransferase values more than 3 times normal History of Deep venous thrombosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testosterone Replacement<br>The experimental group will receive 0.5 ml (100 mg) testosterone cypionate Intramuscular injections each week for 11 weeks. | Drug: Testosterone<br>* Testosterone Cypionate Intramuscular injections will be administered weekly<br>* Other names: testosterone cypionate;|
| Placebo Comparator: Control<br>Patients in the control group will receive intramuscular normal saline injections. | Drug: Normal Saline<br>* Normal Saline Intramuscular injections will be administered weekly<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Equivalent |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test |  | 12 weeks |