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

Completed · Phase 2/Phase 3

Conditions studied: Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT00063687

Run by

Advanz Pharma

People needed

400

Starts

2003-03-01

Expected to finish

2005-06-01

Last updated by the study team

2005-08-05

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Carr-Dzindzio Cardiology — Oceanside, California, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Saint Vincents Hospital and Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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