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Intravenous Allopurinol in Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00181155
First Posted: September 16, 2005
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert G. Weiss, Johns Hopkins University
September 12, 2005
September 16, 2005
November 11, 2015
February 9, 2016
May 30, 2017
November 2004
December 2010   (Final data collection date for primary outcome measure)
  • Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion [ Time Frame: Onset of imaging acquisition. ]
    Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion
  • Myocardial CK Flux Post Intravenous Allopurinol Infusion. [ Time Frame: acute (within 15 minutes of single infusion) ]
    The mean rate of adenosine triphosphate (ATP) flux through the creatine kinase reaction in the heart.
Myocardial CK flux
Complete list of historical versions of study NCT00181155 on ClinicalTrials.gov Archive Site
  • Cardiac PCr/ATP Pre Intravenous Infusion [ Time Frame: Onset of image acquisition. ]
    The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.
  • Cardiac PCr/ATP Post Intravenous Infusion [ Time Frame: acute (within 15 minutes of single infusion) ]
    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 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Congestive Heart Failure
  • Drug: Allopurinol
    intravenous infusion of allopurinol (300mg)
    Other Name: Aloprim
  • Drug: Placebo
    intravenous infusion of 50 ml dose of 5% dextrose
    Other Name: 5% Dextrose
  • Experimental: Allopurinol
    One time intravenous administration of Allopurinol 300 mg infused over approximately 20 minutes.
    Intervention: Drug: Allopurinol
  • Placebo Comparator: Placebo
    One time intravenous administration of 50 ml dose of 5% dextrose infused over approximately 20 minutes.
    Intervention: Drug: Placebo
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.
 
Completed
18
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00181155
IRB: 04-10-12-06
5R01HL061912-14 ( U.S. NIH Grant/Contract )
No
Not Provided
Plan to Share IPD: No
Robert G. Weiss, Johns Hopkins University
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Robert G Weiss, MD Johns Hopkins University
Johns Hopkins University
April 2017

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