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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Congestive Heart Failure
Interventions: Drug: Allopurinol
Drug: Placebo

  Participant Flow

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
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 
Physician Decision                1                0 
Withdrawal by Subject                1                0 

  Baseline Characteristics

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
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 31-Phosphorus (31P) magnetic resonance spectroscopy.

Baseline Measures
   Intravenous Allopurinol 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      13 100.0% 
>=65 years      0   0.0% 
[Units: Years]
Mean (Standard Deviation)
 47.8  (12.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      4  30.8% 
Male      9  69.2% 
Region of Enrollment 
[Units: Participants]
United States   13 

  Outcome Measures

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

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

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

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

Responsible Party: Robert G. Weiss, Johns Hopkins University Identifier: NCT00181155     History of Changes
Other Study ID Numbers: IRB: 04-10-12-06
5R01HL061912-14 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: November 11, 2015
Results First Posted: February 9, 2016
Last Update Posted: May 30, 2017