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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00987415
Recruitment Status : Completed
First Posted : October 1, 2009
Results First Posted : October 20, 2014
Last Update Posted : November 4, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Elevated Serum Uric Acid Drug: allopurinol Drug: sugar pill Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients
Study Start Date : May 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Change in Submaximal Exercise Capacity (6-MWT) [ Time Frame: Baseline to 12 weeks ]
    6-Minute Walk Test

  3. 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.

  4. Change in Submaximal Exercise Capacity (6-MWT) [ Time Frame: Baseline to 24 weeks ]
    6-Minute Walk Test


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987415


Locations
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United States, Georgia
Morehouse School of Medicine
Atlanta, Georgia, United States
United States, Massachusetts
Harvard University
Boston, Massachusetts, United States
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
United States, Ohio
University Hospitals-Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Texas
Baylor College of Medicine
Houston, Texas, United States
United States, Utah
Univ. of Utah Health Sciences Center
Salt Lake City, Utah, United States
United States, Vermont
University of Vermont
Burlington, Vermont, United States
Canada
University of Montreal
Montreal PQ, Canada
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Study Chair: Eugene Braunwald, MD Harvard University
Study Director: Alice Mascette, MD National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Adrian Hernandez, MD Duke University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00987415    
Other Study ID Numbers: Pro00020011
5U10HL084904 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2009    Key Record Dates
Results First Posted: October 20, 2014
Last Update Posted: November 4, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
 Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs