Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Allopurinol in Heart Failure

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.
 
ClinicalTrials.gov Identifier: NCT00181155
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : February 9, 2016
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert G. Weiss, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 16, 2005
Results First Submitted Date  ICMJE November 11, 2015
Results First Posted Date  ICMJE February 9, 2016
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE November 2004
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Myocardial CK flux
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Cardiac PCr/ATP
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Allopurinol in Heart Failure
Official Title  ICMJE Effects of Xanthine Oxidase Inhibition on Mechano-Energetic Coupling in Heart Failure
Brief Summary This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Congestive Heart Failure
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2016)
18
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00181155
Other Study ID Numbers  ICMJE IRB: 04-10-12-06
5R01HL061912-14 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robert G. Weiss, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Robert G Weiss, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date April 2017

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