Heart Failure Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

400

Study ID:

NCT00063687

Recruitment Status:

Completed

Sponsor:

Advanz Pharma

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There are 4 Locations for this study

See Locations Near You

Carr-Dzindzio Cardiology
Oceanside California, 92056, United States
Johns Hopkins University
Baltimore Maryland, 21287, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
Saint Vincents Hospital and Medical Center
New York New York, 10011, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

400

Study ID:

NCT00063687

Recruitment Status:

Completed

Sponsor:


Advanz Pharma

How clear is this clinincal trial information?

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