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



Status:Recruiting
Conditions:Cardiology, Endocrine
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:18 - Any
Updated:12/7/2018
Start Date:August 2016
End Date:December 2019
Contact:Craig W Spellman, DO
Email:craig.spellman@ttuhsc.edu
Phone:4327035347

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

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.

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

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
We found this trial at
1
site
Odessa, Texas 79765
Phone: 432-640-1472
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Odessa, TX
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