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

NCT01469988 | Terminated Phase 2 DMC

• 1 other identifier: 82-VH-01
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 7

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• In patients with chronic heart failure, does 26 weeks of treatment with transdermal testosterone improve peak VO2?

  The primary endpoint is change in peak VO2 measured at baseline and 26 weeks. The timing of the primary endpoint was chosen to allow for effects of either therapy to be seen within a reasonable timeframe, and to minimize loss to follow up, withdrawal due to clinical or adverse events and published data thus far supporting that an effect could be seen within 26 weeks.

  26 weeks

Secondary Outcomes (2)

• In patients with chronic heart failure, does 26 or 52 weeks of treatment with transdermal testosterone improve quality of life, biomarker (b-type natriuretic peptide, fasting glucose) or echocardiographic measures (LVEF, LVEDD, LVESD, SV)?

  52 weeks

• In patients with chronic heart failure, does 52 weeks of treatment with transdermal testosterone reduce ED visits or hospitalization for heart failure, or total mortality?

  52 weeks

Study Arms (2)

Testosterone

EXPERIMENTAL

Drug: Testosterone

Placebo

PLACEBO COMPARATOR

Drug: Testosterone

Interventions

Testosterone DRUG

Patients will be dosed accordingly: Female: 0.3g once daily (or matching placebo) gel;Males: 5g once daily (or matching placebo) gel.

Placebo; Testosterone

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (7)

Ajax / Pickering

Ajax, Canada

Location

Brampton (McMaster University)

Brampton, Canada

Location

Foothills Hospital (University of Calgary)

Calgary, Canada

Location

The University of Alberta (Mazankowski Alberta Heart Institute):

Edmonton, Canada

Location

Surrey Memorial Hospital (University of British Columbia)

Surrey, Canada

Location

Toronto General Hospital (University of Toronto):

Toronto, Canada

Location

Vancouver General Hospital (University of British Columbia)

Vancouver, Canada

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Justin Ezekowitz

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 10, 2011
• Study Start: November 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 23, 2018

Record last verified: 2014-04

Locations

CA (7)