Study Stopped
Infeasible
Intravenous Allopurinol to Improve Heart Function in Individuals With Dilated Cardiomyopathy
Allopurinol and Cardiac Function Pilot Study in Idiopathic Dilated Cardiomyopathy
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
This study will determine whether an acute infusion of intravenous allopurinol improves the inotropic response to dobutamine in patients with idiopathic dilated cardiomyopathy (DCM) as measured by cardiac magnetic resonance imaging (CMR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2003
Longer than P75 for phase_1 cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 20, 2006
CompletedFirst Posted
Study publicly available on registry
January 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 19, 2013
June 1, 2013
10 years
January 20, 2006
June 17, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
radial and circumferential strain after infusion of allopurinol as measured by cardiac MRI (measured at Day 1)
Study Arms (2)
allopurinol
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of idiopathic cardiomyopathy (defined by an ejection fraction less than or equal to 35% that has been assessed by any method within 6 months prior to study entry AND no evidence of coronary artery disease, as determined by coronary angiography or stress perfusion imaging within 2 years prior to study entry)
- New York Heart Association (NYHA) Class I - II heart failure
- Stable heart failure medication for at least 1 month prior to study entry
- Able to lie flat for 45 minutes
You may not qualify if:
- History of poorly controlled hypertension and concentric left ventricular hypertrophy on echocardiography suggesting hypertensive cardiomyopathy
- History of biopsy-proven myocarditis
- Peripartum cardiomyopathy
- Allopurinol therapy within the 6 months prior to study entry
- Allopurinol allergy
- Contraindication to allopurinol because of concomitant therapy with one of the following: azathioprine, cyclophosphamide, dicumarol, uricosuric agents (e.g., probenecid), ampicillin, amoxicillin, chlorpropamide, or cyclosporine
- Acute gout
- Estimated creatinine clearance less than 20 ml/min
- Total bilirubin greater than 2 times upper limit of normal
- Serum aspartate AST or alanine ALT greater than 3 times the upper limit of normal
- White blood cell count less than 2,000
- Platelet count less than 80,000
- Hemoglobin less than 8 mg/dl
- Use of intravenous inotropes
- History of untreated symptomatic ventricular tachycardia
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Thomas P. Cappola
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
January 20, 2006
First Posted
January 24, 2006
Study Start
June 1, 2003
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
June 19, 2013
Record last verified: 2013-06