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

Phase 2

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
sugar pill	sugar pill	Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol	allopurinol	Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.

Primary Outcome Measures

Name	Time	Method
A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.	24 Weeks	CCE composed of 3-level categorical variable with options that include worsened, unchanged or improved

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life (KCCQ).	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.
Change in Submaximal Exercise Capacity (6-MWT)	Baseline to 24 weeks	6-Minute Walk Test
Change in Quality of Life (KCCQ)	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.

Locations (10): University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
Morehouse School of Medicine
🇺🇸
Atlanta, Georgia, United States
University Hospitals-Case Medical Center
🇺🇸
Cleveland, Ohio, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
Harvard University
🇺🇸
Boston, Massachusetts, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Univ. of Utah Health Sciences Center
🇺🇸
Salt Lake City, Utah, United States
University of Montreal
🇨🇦
Montreal PQ, Canada
University of Vermont
🇺🇸
Burlington, Vermont, United States