NCT00181155

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

February 9, 2016

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

6.1 years

First QC Date

September 12, 2005

Results QC Date

November 11, 2015

Last Update Submit

April 28, 2017

Conditions

Congestive Heart Failure

Keywords

metabolismcongestive heart failureallopurinolAdenosine triphosphate (ATP)

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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)

Secondary Outcomes (2)

  • Cardiac PCr/ATP Pre Intravenous Infusion

    Onset of image acquisition.

  • Cardiac PCr/ATP Post Intravenous Infusion

    acute (within 15 minutes of single infusion)

Study Arms (2)

Allopurinol

EXPERIMENTAL

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

Drug: Allopurinol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AllopurinolDRUG

intravenous infusion of allopurinol (300mg)

Also known as: Aloprim
Allopurinol
PlaceboDRUG

intravenous infusion of 50 ml dose of 5% dextrose

Also known as: 5% Dextrose
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • 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.

    PMID: 22361399DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

AllopurinolGlucose

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHexosesMonosaccharidesSugarsCarbohydrates

Limitations and Caveats

The limitations of the current study include the small placebo group sample size and the etiologic heterogeneity of the nonischemic cardiomyopathy group.

Results Point of Contact

Title
Robert G. Weiss, MD
Organization
Johns Hopkins University
rweiss@jhmi.edu
410-955-1703

Study Officials

  • Robert G Weiss, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Radiology

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

November 1, 2004

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 30, 2017

Results First Posted

February 9, 2016

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)