NCT00063687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

August 5, 2005

Status Verified

July 1, 2003

First QC Date

July 2, 2003

Last Update Submit

August 3, 2005

Conditions

Congestive Heart Failure

Interventions

OxypurinolDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Carr-Dzindzio Cardiology

Oceanside, California, 92056, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Saint Vincents Hospital and Medical Center

New York, New York, 10011, United States

Location

Related Publications (1)

  • 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.

    PMID: 18549913DERIVED

Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

Oxypurinol

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Joshua Hare, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 2, 2003

First Posted

July 3, 2003

Study Start

March 1, 2003

Study Completion

June 1, 2005

Last Updated

August 5, 2005

Record last verified: 2003-07

Locations

US(4)