The VO2 Increase With Testosterone Addition - Heart Failure (VITA-HF) Trial

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the efficacy and safety of testosterone supplementation on functional capacity, biomarkers, quality of life and clinical outcomes for patients with heart failure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Age > 40 years

• NYHA Class II - III

• Left ventricular ejection fraction available by echo, nuclear or MRI < 12 months

• On optimal medical therapy (as per CCS guidelines for Chronic Heart Failure)42 for >3 months

• Female patients only: participants must be >1 year post-menopausal (defined as 12 months of spontaneous amenorrhea and confirmed by screening FSH >40 mIU/mL) OR >6 weeks post surgical bilateral oophorectomy if surgically sterilized.

Exclusion Criteria:

• Already or likely to receive LVAD or organ transplant within 6 months

• History of illicit drug use or alcohol abuse within <3 months, or history of HIV, Hepatitis B or C

• History of hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, clinically significant congenital heart disease, severe aortic or mitral regurgitation or stenosis

• Non-cardiovascular diagnosis with reduced life expectancy < 1 year including active cancer

• Recent (<1 month) cardiovascular event (admission to hospital for unstable angina, acute coronary syndrome, hypertensive crisis or ventricular arrhythmia) or cerebrovascular event (transient ischemic attack or stroke) or recent (<3 months) implantation of cardiac resynchronization therapy

• Hematocrit > 48%

• Male patients only: PSA > 4 ng/ml, or presence of a prostate nodule

• Total serum testosterone > 350 ng/dl (12.1 nmol/L)

• Untreated severe obstructive sleep apnea per American Thoracic Society criteria

• Chronic glucocorticoid, or anabolic steroid therapy

• Chronic hemodialysis, serum creatinine > 264 umol/L (3 mg/dL) or eGFR< 15 ml/min (MDRD)

• Participation in a competing trial