Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocarditis; Giant Cell Myocarditis
Intervention: Cyclosporine (Drug); methylprednisolone (Drug); Muromonab-CD3 (Drug); prednisone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): Leslie T. Cooper, Jr., Study Chair, Affiliation: Mayo Clinic
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.
Clinical Details
Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Detailed description:
PROTOCOL OUTLINE:
This is a randomized, open label, multicenter study.
Patients are randomized to receive standard care with immunosuppression (arm I) or standard
care with or without immunosuppression (no muromonab-CD3 or cyclosporine)(arm II).
Arm I: Patients receive methylprednisolone IV once daily for 3 days and muromonab-CD3 IV
once daily for 10 days. Oral cyclosporine is administered twice daily and oral prednisone is
administered once daily for 1 year.
Arm II: Patients receive standard care with or without immunosuppression (no muromonab-CD3
or cyclosporine).
Patients are followed for one year.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Starting date: December 1999
Last updated: September 8, 2010
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