Congestive Heart Failure
Conditions
Brief summary
The OPT-CHF (OxyPurinol Therapy for CHF) study is designed to demonstrate the efficacy and safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial in 400 patients in up to 50 centers. Measures of clinical efficacy (NYHA class and Patient Global Assessment) as well as clinical outcomes (e.g., death, worsening heart failure, and hospitalization) will be assessed as a composite endpoint in this trial.
Interventions
DRUGOxypurinol
Sponsors
Advanz Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 18-85 years old, * Stable NYHA Class III-IV * Hospitalization or ER visits in past 18 months for worsening Heart Failure (or addition of new heart failure medication added to regimen due to lack of stability on current regimen. * EF =\< 40%
Exclusion criteria
* Any condition (other than CHF) that could limit exercise * Any concurrent disease likely to limit life expectancy. * Participation in another clinical trial * Primary valvular disease, active myocarditis, or an obstructive or restrictive cardio-myopathy * Heart Attack, Stroke, Unstable Angina or Cardiac surgery within previous 3 months
Countries
United States
Outcome results
None listed