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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:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181155
First received: September 12, 2005
Last updated: October 19, 2010
Last verified: September 2008

September 12, 2005
October 19, 2010
November 2004
May 2009   (final data collection date for primary outcome measure)
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.
Myocardial CK flux
Complete list of historical versions of study NCT00181155 on ClinicalTrials.gov Archive Site
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.
cardiac PCr/ATP
Not Provided
Not Provided
 
Intravenous Allopurinol in Heart Failure
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Congestive Heart Failure
Drug: allopurinol 300mg intravenous
intravenous infusion of allopurinol (300mg) or placebo
Not Provided
Hirsch GA, Bottomley PA, Gerstenblith G, Weiss RG. Allopurinol acutely increases adenosine triphospate energy delivery in failing human hearts. J Am Coll Cardiol. 2012 Feb 28;59(9):802-8. doi: 10.1016/j.jacc.2011.10.895.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2010
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Robert G Weiss, MD 410-955-1703 rweiss@jhmi.edu
United States
 
NCT00181155
HL61912; 04-10-12-06, HL61912, IRB 04-10-12-06
Not Provided
Robert G. Weiss, M.D., Johns Hopkins University School of Medicine
Johns Hopkins University
National Institutes of Health (NIH)
Principal Investigator: Robert G Weiss, MD Johns Hopkins University
Johns Hopkins University
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP