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

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure, Elevated Serum Uric Acid

In brief

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.

Key facts

Study ID

NCT00987415

Run by

Duke University

People needed

253

Starts

2010-05-01

Expected to finish

2014-06-01

Last updated by the study team

2014-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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