Intravenous Allopurinol in Heart Failure

April 28, 2017 updated by: Robert G. Weiss, Johns Hopkins University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allopurinol
One time intravenous administration of Allopurinol 300 mg infused over approximately 20 minutes.
Drug: Allopurinol
intravenous infusion of allopurinol (300mg)
Other Names:
  • Aloprim
Placebo Comparator: Placebo
One time intravenous administration of 50 ml dose of 5% dextrose infused over approximately 20 minutes.
Drug: Placebo
intravenous infusion of 50 ml dose of 5% dextrose
Other Names:
  • 5% Dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Onset of imaging acquisition.
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.
acute (within 15 minutes of single infusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Onset of image acquisition.
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.
acute (within 15 minutes of single infusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB: 04-10-12-06
  • 5R01HL061912-14 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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