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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
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181155
First received: September 12, 2005
Last updated: October 19, 2010
Last verified: September 2008
History of Changes
  Purpose

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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181155

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

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Tricia Steinberg, RN     443-287-3469     asteinb3@jhmi.edu    
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Robert G. Weiss, M.D., Johns Hopkins University School of Medicine
ClinicalTrials.gov 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:
metabolism
congestive heart failure
allopurinol
ATP

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Allopurinol
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
 Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013