Phase 2
Completed N=253
Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels
Heart Failure · Elevated Serum Uric Acid
Source: ClinicalTrials.gov NCT00987415 ↗
Enrolled (actual)
253
Serious AEs
17.4%
Results posted
Oct 2014
Primary outcomePrimary: A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged. — 58; 58; 54; 43 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged. |
58; 58; 54; 43; 16; 24 | — |
| SECONDARY Change in Quality of Life (KCCQ). |
4.45; 3.38 | — |
| SECONDARY Change in Submaximal Exercise Capacity (6-MWT) |
18.1; 20.7 | — |
| SECONDARY Change in Quality of Life (KCCQ) |
1.13; 4.68 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00987415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.