This study examines the effect of testosterone replacement on the ability to exercise for men with functional competence of the gonads after a recent heart attack.
This is a randomized, interventional double-blind, parallel assignment with an estimated 60 participants. The study began in August 2016 and is estimated to be completed by December 2019.
- 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
- 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
You may participate in this clinical trial at Mission Fitness-Medical Center Hospital in Odessa, Texas, United States, 79765. If you have any questions or concerns, contact Ryan Baldomero, DNP at 432-640-1472 or at RBaldomero@echd.org.
This study is sponsored by Texas Tech University Health Sciences Center with Osama Mukkaram, MD, Craig W Spellman, DO, and Sandeep Dhindsa, MD as the Principal Investigators.
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