Intravenous Allopurinol in Heart Failure

NCT ID: NCT00181155

Last Updated: 2017-05-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Allopurinol

One time intravenous administration of Allopurinol 300 mg infused over approximately 20 minutes.

Group Type EXPERIMENTAL

Allopurinol

Intervention Type DRUG

intravenous infusion of allopurinol (300mg)

Placebo

One time intravenous administration of 50 ml dose of 5% dextrose infused over approximately 20 minutes.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

intravenous infusion of 50 ml dose of 5% dextrose

Interventions

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Allopurinol

intravenous infusion of allopurinol (300mg)

Intervention Type DRUG

Placebo

intravenous infusion of 50 ml dose of 5% dextrose

Intervention Type DRUG

Other Intervention Names

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Aloprim 5% Dextrose

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Robert G. Weiss

Professor of Medicine and Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert G Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22361399 (View on PubMed)

Other Identifiers

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5R01HL061912-14

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB: 04-10-12-06

Identifier Type: -

Identifier Source: org_study_id

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