Intravenous Allopurinol in Heart Failure

Phase 2

Completed

• Conditions: Congestive Heart Failure
• Interventions: Drug: Placebo; Drug: Allopurinol

• Registration Number: NCT00181155
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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 Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2015-11-11
• Results First Submitted QC: 2016-01-06
• Results First Posted: 2016-02-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	One time intravenous administration of 50 ml dose of 5% dextrose infused over approximately 20 minutes.
Allopurinol	Allopurinol	One time intravenous administration of Allopurinol 300 mg infused over approximately 20 minutes.

Primary Outcome Measures

Name	Time	Method
Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion	Onset of imaging acquisition.	Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion
Myocardial CK Flux Post Intravenous Allopurinol Infusion.	acute (within 15 minutes of single infusion)	The mean rate of adenosine triphosphate (ATP) flux through the creatine kinase reaction in the heart.

Secondary Outcome Measures

Name	Time	Method
Cardiac PCr/ATP Post Intravenous Infusion	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.
Cardiac PCr/ATP Pre Intravenous Infusion	Onset of image acquisition.	The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States