Phase 2
N=253
Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels
Heart Failure · Elevated Serum Uric Acid
Bottom Line
View on ClinicalTrials.gov: NCT00987415 ↗Enrolled (actual)
253
Serious AEs
17.4%
Results posted
Oct 2014
Primary outcome: Primary: A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged. — 58; 58; 54; 43 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- allopurinol (Drug); sugar pill (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Dec 2013
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 | — |
| SECONDARY Change in Submaximal Exercise Capacity (6-MWT) |
18.1; 20.7 | — |
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 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.