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Intravenous Allopurinol in Heart Failure

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Allopurinol
Placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring metabolism, congestive heart failure, allopurinol, Adenosine triphosphate (ATP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Allopurinol

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion
Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion
Myocardial CK Flux Post Intravenous Allopurinol Infusion.
The mean rate of adenosine triphosphate (ATP) flux through the creatine kinase reaction in the heart.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 12, 2005
Last Updated
April 28, 2017
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00181155
Brief Title
Intravenous Allopurinol in Heart Failure
Official Title
Effects of Xanthine Oxidase Inhibition on Mechano-Energetic Coupling in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
metabolism, congestive heart failure, allopurinol, Adenosine triphosphate (ATP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allopurinol
Arm Type
Experimental
Arm Description
One time intravenous administration of Allopurinol 300 mg infused over approximately 20 minutes.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One time intravenous administration of 50 ml dose of 5% dextrose infused over approximately 20 minutes.
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Other Intervention Name(s)
Aloprim
Intervention Description
intravenous infusion of allopurinol (300mg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
5% Dextrose
Intervention Description
intravenous infusion of 50 ml dose of 5% dextrose
Primary Outcome Measure Information:
Title
Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion
Description
Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion
Time Frame
Onset of imaging acquisition.
Title
Myocardial CK Flux Post Intravenous Allopurinol Infusion.
Description
The mean rate of adenosine triphosphate (ATP) flux through the creatine kinase reaction in the heart.
Time Frame
acute (within 15 minutes of single infusion)
Secondary Outcome Measure Information:
Title
Cardiac PCr/ATP Pre Intravenous Infusion
Description
The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.
Time Frame
Onset of image acquisition.
Title
Cardiac PCr/ATP Post Intravenous Infusion
Description
The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.
Time Frame
acute (within 15 minutes of single infusion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Weiss, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22361399
Citation
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.
Results Reference
derived

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Intravenous Allopurinol in Heart Failure

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