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Intravenous Allopurinol in Heart Failure

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert G. Weiss, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181155
First received: September 12, 2005
Last updated: January 6, 2016
Last verified: January 2016
Results First Received: November 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Congestive Heart Failure
Interventions: Drug: Allopurinol
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with Non-Ischemic Cardiomyopathy were recruited as approved by the Johns Hopkins Institutional Review Board for Human Investigation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study drug allocation was randomized in a 4:1 fashion by the research pharmacy. Participants were randomized to Placebo only for the purposes of blinding; Adverse Events were collected for the Placebo arm.

Reporting Groups
  Description
Allopurinol Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.
Placebo Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.

Participant Flow:   Overall Study
    Allopurinol     Placebo  
STARTED     15     3  
COMPLETED     13     3  
NOT COMPLETED     2     0  
Physician Decision                 1                 0  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intravenous Allopurinol We randomized patients with nonischemic cardiomyopathy in a double-blind fashion to allopurinol (300 mg intravenously) or placebo infusion, 4-to-1, the latter for purposes of blinding only. The myocardial concentrations of ATP and creatine phosphate (PCr) and the rate of adenosine triphosphate (ATP) synthesis through CK (CK flux) were determined by 31P magnetic resonance spectroscopy.

Baseline Measures
    Intravenous Allopurinol  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     13  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  47.8  (12.9)  
Gender  
[units: participants]
 
Female     4  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     13  



  Outcome Measures
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1.  Primary:   Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion   [ Time Frame: Onset of imaging acquisition. ]

2.  Primary:   Myocardial CK Flux Post Intravenous Allopurinol Infusion.   [ Time Frame: acute (within 15 minutes of single infusion) ]

3.  Secondary:   Cardiac PCr/ATP Pre Intravenous Infusion   [ Time Frame: Onset of image acquisition. ]

4.  Secondary:   Cardiac PCr/ATP Post Intravenous Infusion   [ Time Frame: acute (within 15 minutes of single infusion) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The limitations of the current study include the small placebo group sample size and the etiologic heterogeneity of the nonischemic cardiomyopathy group.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robert G. Weiss, MD
Organization: Johns Hopkins University
phone: 410-955-1703
e-mail: rweiss@jhmi.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Robert G. Weiss, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00181155     History of Changes
Other Study ID Numbers: IRB: 04-10-12-06
5R01HL061912-14 ( US NIH Grant/Contract Award Number )
Study First Received: September 12, 2005
Results First Received: November 11, 2015
Last Updated: January 6, 2016
Health Authority: United States: Institutional Review Board