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

Duke University

Status and phase: Completed; Phase 2

Conditions: Heart Failure; Elevated Serum Uric Acid

Treatments: Drug: sugar pill; Drug: allopurinol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00987415

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

Pro00020011

Details and patient eligibility

About

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.

Enrollment: 253 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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253 participants in 2 patient groups, including a placebo group

allopurinol

Active Comparator group

Description:

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

Treatment:

Drug: allopurinol

sugar pill

Placebo Comparator group

Description:

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

Treatment:

Drug: sugar pill