Intravenous Allopurinol to Improve Heart Function in Individuals With Dilated Cardiomyopathy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00281255
• Date of registration: 20/01/2006
• Prospective Registration: No
• Primary sponsor: University of Pennsylvania
• Public title: Intravenous Allopurinol to Improve Heart Function in Individuals With Dilated Cardiomyopathy
• Scientific title: Allopurinol and Cardiac Function Pilot Study in Idiopathic Dilated Cardiomyopathy
• Date of first enrolment: June 2003
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00281255
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Thomas P. Cappola
• Affiliation: University of Pennsylvania

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- History of sustained ventricular tachycardia induced by dobutamine

- Contraindication to MRI because of one of the following:

1. Starr-Edwards pre-6000 series prosthetic valves or prosthetic valves for which
model can not be determined

2. Implanted pacemaker

3. Implanted cardioverter-defibrillator intracranial aneurysm clips

4. Other implanted medical devices that are known to be MRI incompatible (e.g.,
cochlear implants and spinal stimulators)

5. History of foundry-work that could create ocular metallic fragments

- Hospitalization at least 1 month prior to study entry



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Heart Diseases

Heart Failure, Congestive

Cardiomyopathy, Dilated

Cardiovascular Diseases

Intervention(s)

Drug: Dobutamine

Drug: Allopurinol

Primary Outcome(s)

radial and circumferential strain after infusion of allopurinol as measured by cardiac MRI (measured at Day 1)

Secondary ID(s)

353

K23HL071562

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)