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

Completed · Not applicable

Conditions studied: Myocarditis

In brief

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.

Key facts

Study ID

NCT00027443

Run by

Mayo Clinic

People needed

40

Starts

2001-08-01

Expected to finish

2007-07-01

Last updated by the study team

2015-03-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Idiopathic heart failure and/or arrhythmia of less than 3 months duration
• Endomyocardial biopsy diagnostic of idiopathic giant cell myocarditis
• Negative pregnancy test

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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