Study of Muromonab-CD3 and Cyclosporine in Patients With Giant Cell Myocarditis

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to determine the efficacy of muromonab-CD3 and cyclosporine as treatment in patients with giant cell myocarditis (GCM). T lymphocytes appear to be involved in GCM. Muromonab-CD3 has been shown to reduce the number of lymphocytes and cyclosporine inhibits lymphocyte activation. This treatment may prolong patient survival until transplantation or ventricular assist device placement is possible.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Cyclosporine; Cyclosporins; Muromonab-CD3

Criteria

Inclusion criteria:

• Idiopathic heart failure and/or arrhythmia of less than 3 months duration

• Endomyocardial biopsy diagnostic of idiopathic giant cell myocarditis

• Negative pregnancy test

Exclusion criteria:

• Clinical evidence of sepsis or active infection (e.g., meningitis or osteomyelitis)

• Pregnant

• Any contraindication to immunosuppression

• Allergy to cyclosporine or muromonab-CD3

• Creatinine greater than 2.5 mg/dL

• AST or ALT greater than 3 times upper limit of normal

• Other severe concurrent disease that would preclude study

• Unreliable or uncooperative subject