Intravenous Allopurinol in Heart Failure

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Congestive Heart Failure

Treatments: Drug: Placebo; Drug: Allopurinol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00181155

5R01HL061912-14 (U.S. NIH Grant/Contract)

IRB: 04-10-12-06

Details and patient eligibility

About

This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure.

Full description

Xanthine oxidase have been reported to improve mechano-energetic coupling in failing hearts. The investigators developed a means to directly measure creatine kinase flux, the major energy reserve of the heart, in the human heart exploiting new magnetic resonance technologies.

The investigators propose to study 10 healthy subjects and up to 25 with heart failure (dilated cardiomyopathy) before and after a single 300mg IV infusion of allopurinol.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Allopurinol

Experimental group

Description:

One time intravenous administration of Allopurinol 300 mg infused over approximately 20 minutes.

Treatment:

Drug: Allopurinol

Placebo

Placebo Comparator group

Description:

One time intravenous administration of 50 ml dose of 5% dextrose infused over approximately 20 minutes.

Treatment:

Drug: Placebo