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

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

Details

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