NCT00987415CompletedPhase 2
Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 253
- Locations
- 10
- Primary Endpoint
- A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
allopurinol
Active Comparator
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Intervention: allopurinol (Drug)
sugar pill
Placebo Comparator
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Intervention: sugar pill (Drug)
Outcomes
Primary Outcomes
A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.
Time Frame: 24 Weeks
CCE composed of 3-level categorical variable with options that include worsened, unchanged or improved
Secondary Outcomes
- Change in Quality of Life (KCCQ).(Baseline to 12 weeks)
- Change in Submaximal Exercise Capacity (6-MWT)(Baseline to 24 weeks)
- Change in Quality of Life (KCCQ)(Baseline to 24 weeks)
Investigators
Study Sites (10)
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