Intravenous Allopurinol to Improve Heart Function in Individuals With Dilated Cardiomyopathy

• Status: Withdrawn
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Allopurinol; Dobutamine

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