Acute Myocardial Infarction: Rehabilitation Phase, Hypogonadism
Conditions
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.
Interventions
DRUGTestosterone
Testosterone Cypionate Intramuscular injections will be administered weekly
DRUGNormal Saline
Normal Saline Intramuscular injections will be administered weekly
Sponsors
Texas Tech University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Baseline free testosterone levels less than age-specific normal values. 3. Males 18 years and older
Exclusion criteria
1. 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. 2. Current use of testosterone, clomiphene or over the counter testosterone boosters 3. Patients initiating cardiac rehabilitation 8+ weeks after MI or Non-ST Elevation-Acute Coronary Syndrome 4. Congestive heart failure, New York Heart Association class IV 5. Life expectancy less than 1 year, 6. Baseline hematocrit of \>50% 7. Allergic reactions to testosterone or testosterone vehicle (i.e. cotton seed oil, etc.) 8. Physical inability to participate in rehabilitation program (examples: severe claudication, massive obesity, etc.) 9. Participation in any other concurrent clinical trial, use of an investigational agent or therapeutic regimen within 30 days of study 10. Patients formerly diagnosed with obstructive sleep apnea. 11. Patients using opiate analgesics 12. Patients with aspartate aminotransferase/alanine aminotransferase values more than 3 times normal 13. History of Deep venous thrombosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic Equivalent | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 6 minute walk test | 12 weeks |
Countries
United States
Outcome results
None listed