Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis
NCT ID: NCT00004482
Last Updated: 2010-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
1999-12-31
2006-07-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Cyclosporine
methylprednisolone
Muromonab-CD3
prednisone
Eligibility Criteria
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Inclusion 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Principal Investigators
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Leslie T. Cooper, Jr.
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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MAYOC-1479901
Identifier Type: -
Identifier Source: secondary_id
MAYOC-1479900
Identifier Type: -
Identifier Source: secondary_id
199/14209
Identifier Type: -
Identifier Source: org_study_id