Overview

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

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Treatments:
Allopurinol
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.