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Completed

NCT Number: NCT00987415

Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Elevated Serum Uric Acid Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Montreal, Montreal PQ, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Allopurinol

Drug

Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.

Sugar pill

Drug

Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients

Acronym: EXACT-HF

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Oct 1, 2009
Registry last updated
Nov 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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