Official Title: “Effects of Xanthine Oxidase Inhibition on Mechano-Energetic Coupling in Heart Failure”

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

Study Type: Interventional

Study Design: Other, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2009

Xanthine oxidase have been reported to improve mechano-energetic coupling in failing hearts.

We 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.

We 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.

Intervention(s) in this Clinical Trial

• Drug: allopurinol 300mg intravenous
  • intravenous infusion of allopurinol (300mg) or placebo

Primary Measures

• Myocardial CK flux
  • Time Frame: acute (within 60 minutes of single infusion)
    Safety Issue?: No

Secondary Measures

• Cardiac PCr/ATP
  • Time Frame: acute (within 60 minutes of single infusion)
    Safety Issue?: No

Inclusion Criteria:

• 1. Age > 18 years
• 2. The patient is willing and able to provide informed consent
• 3. Clinical diagnosis of chronic heart failure
• 4. EF < 40% by echocardiography, nuclear MUGA or cath ventriculography
• 5. No significant coronary disease at cardiac catheterization
• 6. NYHA Class I-IV symptoms
• 7. Clinical stabilization for two weeks if following recent CHF decompensation.

Exclusion Criteria:

• 1. Metallic implant prohibiting MR evaluation
• 2. Inability to lie flat for MR study
• 3. Administration of additional investigational drugs
• 4. Calculated creatinine clearance < 50 mL/min
• 5. Allergy to allopurinol
• 6. Current gout flare
• 7. Currently taking oral allopurinol

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johns Hopkins University

Overall Clinical Trial Officials and Contacts

Robert G Weiss, MD Principal Investigator Johns Hopkins  

Overall Contact: Robert G Weiss, MD 410-955-1703 rweiss@jhmi.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00181155

Study ID Number: HL61912; 04-10-12-06

ClinicalTrials.gov Identifier: NCT00181155

Health Authority: United States: Institutional Review Board