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Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004482
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : September 9, 2010
Information provided by:
Mayo Clinic

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Myocarditis Giant Cell Myocarditis Drug: Cyclosporine Drug: methylprednisolone Drug: Muromonab-CD3 Drug: prednisone Phase 2

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 1999
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004482

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Study Chair: Leslie T. Cooper, Jr. Mayo Clinic
Layout table for additonal information Identifier: NCT00004482    
Other Study ID Numbers: 199/14209
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: September 9, 2010
Last Verified: September 2010
Keywords provided by Mayo Clinic:
cardiovascular and respiratory diseases
giant cell myocarditis
rare disease
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents