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Completed

NCT Number: NCT00181155

Intravenous Allopurinol in Heart Failure

This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allopurinol

Drug

intravenous infusion of allopurinol (300mg)

Other names: Aloprim

Placebo

Drug

intravenous infusion of 50 ml dose of 5% dextrose

Other names: 5% Dextrose

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Effects of Xanthine Oxidase Inhibition on Mechano-Energetic Coupling in Heart Failure

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2005
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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