Oxypurinol Compared With Placebo for Class III-IV NYHA Congestive Heart Failure

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiome Pharma; Correvio International Sarl
• Treatments: Oxypurinol

Criteria

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