Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES:

I. Assess the effect of immunosuppression with muromonab-CD3, cyclosporine, methylprednisolone, and prednisone versus standard care in terms of death, heart transplantation, or left ventricular assistive device placement in patients with giant cell myocarditis.

II. Compare left ventricular ejection fraction prior to and after 4 weeks of treatment in these arms.

III. Compare the degree of myocardial inflammatory infiltrate prior to and after 4 weeks of treatment in these arms.

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

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Cyclosporine; Cyclosporins; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Muromonab-CD3; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Idiopathic giant cell myocarditis confirmed by endomyocardial biopsy

Heart failure and/or arrhythmia of less than 3 months duration

--Patient Characteristics--

Hepatic: AST/ALT no greater than 3 times upper limit of normal

Renal: Creatinine no greater than 2.5 mg/dL

Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No clinical evidence of sepsis or active infection (e.g. meningitis, osteomyelitis, etc.); No contraindication to immunosuppression; No allergy to cyclosporine or muromonab-CD3; No other severe concurrent diseases