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Intravenous Allopurinol in Heart Failure

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert G. Weiss, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181155
First received: September 12, 2005
Last updated: January 6, 2016
Last verified: January 2016
  Purpose
This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure.

Condition Intervention Phase
Congestive Heart Failure
Drug: Allopurinol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Xanthine Oxidase Inhibition on Mechano-Energetic Coupling in Heart Failure

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion [ Time Frame: Onset of imaging acquisition. ] [ Designated as safety issue: No ]
    Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion

  • Myocardial CK Flux Post Intravenous Allopurinol Infusion. [ Time Frame: acute (within 15 minutes of single infusion) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Onset of image acquisition. ] [ Designated as safety issue: No ]
    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 [ Time Frame: acute (within 15 minutes of single infusion) ] [ Designated as safety issue: No ]
    The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.


Enrollment: 18
Study Start Date: November 2004
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allopurinol
One time intravenous administration of Allopurinol 300 mg infused over approximately 20 minutes.
Drug: Allopurinol
intravenous infusion of allopurinol (300mg)
Other Name: Aloprim
Placebo Comparator: Placebo
One time intravenous administration of 50 ml dose of 5% dextrose infused over approximately 20 minutes.
Drug: Placebo
intravenous infusion of 50 ml dose of 5% dextrose
Other Name: 5% Dextrose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181155

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Robert G Weiss, MD Johns Hopkins University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert G. Weiss, Professor of Medicine and Radiology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00181155     History of Changes
Other Study ID Numbers: IRB: 04-10-12-06  5R01HL061912-14 
Study First Received: September 12, 2005
Results First Received: November 11, 2015
Last Updated: January 6, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
metabolism
congestive heart failure
allopurinol
Adenosine triphosphate (ATP)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016