Intravenous Allopurinol in Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Johns Hopkins University.
Recruitment status was  Recruiting
National Institutes of Health (NIH)
Information provided by:
Johns Hopkins University Identifier:
First received: September 12, 2005
Last updated: October 19, 2010
Last verified: September 2008
This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure.

Condition Intervention Phase
Congestive Heart Failure
Drug: allopurinol 300mg intravenous
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effects of Xanthine Oxidase Inhibition on Mechano-Energetic Coupling in Heart Failure

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Myocardial CK flux [ Time Frame: acute (within 60 minutes of single infusion) ] [ Designated as safety issue: No ]
    The mean rate of ATP flux through the creatine kinase reaction in the heart. The units for this measure are: umol/g/sec.

Secondary Outcome Measures:
  • Cardiac PCr/ATP [ Time Frame: acute (within 60 minutes of single infusion) ] [ Designated as safety issue: No ]
    The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.

Estimated Enrollment: 30
Study Start Date: November 2004
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: allopurinol 300mg intravenous
    intravenous infusion of allopurinol (300mg) or placebo
Detailed 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00181155

Contact: Robert G Weiss, MD 410-955-1703

United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Tricia Steinberg, RN    443-287-3469   
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
Principal Investigator: Robert G Weiss, MD Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Robert G. Weiss, M.D., Johns Hopkins University School of Medicine Identifier: NCT00181155     History of Changes
Other Study ID Numbers: HL61912; 04-10-12-06  HL61912  IRB 04-10-12-06 
Study First Received: September 12, 2005
Last Updated: October 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
congestive heart failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Antirheumatic Agents
Enzyme Inhibitors
Free Radical Scavengers
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on February 04, 2016