Status:
COMPLETED
Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure
Elevated Serum Uric Acid
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00987415
Start Date
May 1 2010
End Date
June 1 2014
Last Update
November 4 2014
Active Locations (10)
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1
Morehouse School of Medicine
Atlanta, Georgia, United States
2
Harvard University
Boston, Massachusetts, United States
3
University of Minnesota
Minneapolis, Minnesota, United States
4
Mayo Clinic
Rochester, Minnesota, United States