Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels (EXACT-HF)

October 28, 2014 updated by: Duke University

Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients

The purpose of this study is to determine whether allopurinol is effective in relieving symptoms of patients with heart failure and high blood uric acid levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montreal PQ, Canada
        • University of Montreal
  • United States
    • Georgia
      • Atlanta, Georgia, United States
        • Morehouse School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States
        • Harvard University
    • Minnesota
      • Minneapolis, Minnesota, United States
        • University of Minnesota
      • Rochester, Minnesota, United States
        • Mayo Clinic
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals-Case Medical Center
    • Texas
      • Houston, Texas, United States
        • Baylor College of Medicine
    • Utah
      • Salt Lake City, Utah, United States
        • Univ. of Utah Health Sciences Center
    • Vermont
      • Burlington, Vermont, United States
        • University of Vermont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • NYHA class II-IV heart failure due to ischemic or non-ischemic cardiomyopathy.
  • Left ventricular ejection fraction ≤ 40% by echocardiography- Heart failure symptoms for 3 months despite standard treatment.
  • Serum uric acid level ≥ 9.5 mg/dl.
  • At least one of the following additional markers of increased risk: Hospitalization, ER visit or urgent clinic visit for heart failure requiring IV diuretics within the previous 12 months; Left ventricular ejection fraction ≤ 25; B-type natriuretic peptide level > 250 pg/ml

Exclusion Criteria:

  • Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, biopsy-proven myocarditis, severe stenotic valvular disease, or complex congenital heart disease.
  • Acute coronary syndrome, PCI or CABG within 3 months.
  • Current ventricular assist device or ventricular assist device or heart transplant likely within the next 6 months.
  • Uncontrolled hypertension (i.e., SBP > 170 mm Hg or DBP > 110 mm Hg)
  • Serum creatinine > 3 mg/dL or estimated GFR < 20 ml/min.
  • Evidence of active hepatitis with ALT and AST greater than 3x normal.
  • Any condition other than HF which could limit the ability to perform a 6-minute walk test
  • Any diseases other than HF which are likely to alter the patient's global perception of status or quality of life over a period of 6 months.
  • Receiving treatment with allopurinol currently or within 30 days, or having symptomatic hyperuricemia which requires treatment with allopurinol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: allopurinol
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Drug: allopurinol
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Placebo Comparator: sugar pill
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Drug: sugar pill
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.
Time Frame: 24 Weeks
CCE composed of 3-level categorical variable with options that include worsened, unchanged or improved
24 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life (KCCQ).
Time Frame: Baseline to 12 weeks
Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Baseline to 12 weeks
Change in Submaximal Exercise Capacity (6-MWT)
Time Frame: Baseline to 12 weeks
6-Minute Walk Test
Baseline to 12 weeks
Change in Quality of Life (KCCQ)
Time Frame: Baseline to 24 weeks
Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Baseline to 24 weeks
Change in Submaximal Exercise Capacity (6-MWT)
Time Frame: Baseline to 24 weeks
6-Minute Walk Test
Baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Study Director: Alice Mascette, MD, National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

September 30, 2009

First Posted (Estimate)

October 1, 2009

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00020011
  • 5U10HL084904 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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