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

Brief Title

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


Brief 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.
    

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.
    

Study Phase

Phase 2

Study Type

Interventional




Condition

Myocarditis

Intervention

Cyclosporine


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

December 1999

Completion Date

July 2006

Primary Completion Date

July 2005

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Leslie T. Cooper, Jr., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00004482

Organization ID

199/14209

Secondary IDs

MAYOC-1479901


Study Sponsor

Mayo Clinic


Study Sponsor

Leslie T. Cooper, Jr., Study Chair, Mayo Clinic


Verification Date

September 2010