Clinical trial NCT02803073: Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After a Recent Myocardial Infarction
Official title: Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After A Recent Myocardial Infarction.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Hypogonadism
Acute Myocardial Infarction: Rehabilitation Phase
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic Equivalent
timeFrame: 12 weeks
Secondary outcomes:
measure: 6 minute walk test
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Odessa
country: United States
facility: Mission Fitness-Medical Center Hospital
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Osama Mukarram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Tech University Health Sciences Center
name: Craig W Spellman, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Tech University Health Sciences Center
name: Sandeep Dhindsa, MD
role: PRINCIPAL_INVESTIGATOR
References: