Intravenous Allopurinol in Heart Failure

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00181155
• Other study ID #: IRB: 04-10-12-06
• Secondary ID: 5R01HL061912-14
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: January 6, 2016
• Start date: November 2004
• Est. completion date: December 2010

Study information

• Verified date: January 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > 18 years

2. The patient is willing and able to provide informed consent

3. Clinical diagnosis of chronic heart failure

4. Ejection fraction (EF) < 40% by echocardiography, nuclear multigated acquisition (MUGA) or cath ventriculography

5. No significant coronary disease at cardiac catheterization

6. New York Heart Association (NYHA) Class I-IV symptoms

7. Clinical stabilization for two weeks if following recent congestive heart failure (CHF) decompensation.

Exclusion Criteria:

1. Metallic implant prohibiting magnetic resonance (MR) evaluation

2. Inability to lie flat for MR study

3. Administration of additional investigational drugs

4. Calculated creatinine clearance < 50 mL/min

5. Allergy to allopurinol

6. Current gout flare

7. Currently taking oral allopurinol

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• Allopurinol
intravenous infusion of allopurinol (300mg)
• Placebo
intravenous infusion of 50 ml dose of 5% dextrose

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion	Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion	Onset of imaging acquisition.	No
Primary	Myocardial CK Flux Post Intravenous Allopurinol Infusion.	The mean rate of adenosine triphosphate (ATP) flux through the creatine kinase reaction in the heart.	acute (within 15 minutes of single infusion)	No
Secondary	Cardiac PCr/ATP Pre Intravenous Infusion	The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.	Onset of image acquisition.	No
Secondary	Cardiac PCr/ATP Post Intravenous 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)	No