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| Sponsor: | Mayo Clinic |
|---|---|
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00004482 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocarditis Giant Cell Myocarditis |
Drug: Cyclosporine Drug: methylprednisolone Drug: Muromonab-CD3 Drug: prednisone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment |
| Estimated Enrollment: | 40 |
| Study Start Date: | December 1999 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
| Study ID Numbers: | 199/14209, MAYOC-1479901, MAYOC-1479900 |
| Study First Received: | October 18, 1999 |
| Last Updated: | October 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004482 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
cardiovascular and respiratory diseases giant cell myocarditis rare disease |
|
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Hormones Neuroprotective Agents Cyclosporins |
Muromonab-CD3 Antifungal Agents Therapeutic Uses Cardiovascular Diseases Myocarditis Dermatologic Agents Methylprednisolone Hemisuccinate Heart Diseases Antineoplastic Agents, Hormonal Gastrointestinal Agents Methylprednisolone acetate Enzyme Inhibitors Glucocorticoids Protective Agents Cardiomyopathies |
