Phase 2
N=18
Intravenous Allopurinol in Heart Failure
Congestive Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00181155 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion — 2.07 umol/g/sec
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Allopurinol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion |
2.07 | — |
| PRIMARY Myocardial CK Flux Post Intravenous Allopurinol Infusion. |
2.87 | <0.007 sig |
| SECONDARY Cardiac PCr/ATP Pre Intravenous Infusion |
1.58 | — |
| SECONDARY Cardiac PCr/ATP Post Intravenous Infusion |
1.75 | <0.02 sig |
Summary
This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure.
Eligibility Criteria
Inclusion Criteria
- Age > 18 years
- The patient is willing and able to provide informed consent
- Clinical diagnosis of chronic heart failure
- Ejection fraction (EF) < 40% by echocardiography, nuclear multigated acquisition (MUGA) or cath ventriculography
- No significant coronary disease at cardiac catheterization
- New York Heart Association (NYHA) Class I-IV symptoms
- Clinical stabilization for two weeks if following recent congestive heart failure (CHF) decompensation.
Exclusion Criteria
- Metallic implant prohibiting magnetic resonance (MR) evaluation
- Inability to lie flat for MR study
- Administration of additional investigational drugs
- Calculated creatinine clearance < 50 mL/min
- Allergy to allopurinol
- Current gout flare
- Currently taking oral allopurinol
Data sourced from ClinicalTrials.gov (NCT00181155). 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.