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

NCT ID: NCT00063687

Last Updated: 2005-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Oxypurinol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanz Pharma

INDUSTRY

Sponsor Role lead

Principal Investigators

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Joshua Hare, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Carr-Dzindzio Cardiology

Oceanside, California, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Saint Vincents Hospital and Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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Hare JM, Mangal B, Brown J, Fisher C Jr, Freudenberger R, Colucci WS, Mann DL, Liu P, Givertz MM, Schwarz RP; OPT-CHF Investigators. Impact of oxypurinol in patients with symptomatic heart failure. Results of the OPT-CHF study. J Am Coll Cardiol. 2008 Jun 17;51(24):2301-9. doi: 10.1016/j.jacc.2008.01.068.

Reference Type DERIVED
PMID: 18549913 (View on PubMed)

Related Links

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http://www.cardiome.com

Related Info

Other Identifiers

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500-02-01

Identifier Type: -

Identifier Source: org_study_id