Status:
TERMINATED
The VO2 Increase With Testosterone Addition - Heart Failure (VITA-HF) Trial
Lead Sponsor:
University of Alberta
Conditions:
Heart Failure
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
Evaluate the efficacy and safety of testosterone supplementation on functional capacity, biomarkers, quality of life and clinical outcomes for patients with heart failure.
Detailed Description
Background:Heart failure is a prevalent condition of major public health importance that leads to significant morbidity and mortality despite the use of current evidence-based therapy. Further develop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT01469988
Start Date
November 1 2012
End Date
April 1 2014
Last Update
January 23 2018
Active Locations (7)
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1
Ajax / Pickering
Ajax, Canada
2
Brampton (McMaster University)
Brampton, Canada
3
Foothills Hospital (University of Calgary)
Calgary, Canada
4
The University of Alberta (Mazankowski Alberta Heart Institute):
Edmonton, Canada