Study of Muromonab-CD3 and Cyclosporine in Patients With Giant Cell Myocarditis

NCT ID: NCT00027443

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2007-07-31

Brief Summary

This is a study to determine the efficacy of muromonab-CD3 and cyclosporine as treatment in patients with giant cell myocarditis (GCM). T lymphocytes appear to be involved in GCM. Muromonab-CD3 has been shown to reduce the number of lymphocytes and cyclosporine inhibits lymphocyte activation. This treatment may prolong patient survival until transplantation or ventricular assist device placement is possible.

Detailed Description

Each patient will be randomized to receive either standard care and immunosuppression therapy (treatment group) or standard care alone (control group). To prevent bias, randomization will be stratified by recency of symptom onset to ensure that both the treatment and control groups are balanced with respect to it. Within each of these 2 strata, permuted-block randomization will be done to keep the number of treatment and control patients balanced. Due to the necessary monitoring of the patients randomized to receive immunosuppression therapy, treatment cannot be blinded. Approximately 1 year after the last patient has been randomized, the observed times from randomization to the composite endpoint (death, transplantation, or LVD placement) will be compared in the treatment and control groups.

Completion date provided represents the completion date of the grant per OOPD records

Conditions

Myocarditis

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Muromonab-CD3

Intervention Type: DRUG

Cyclosporine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Idiopathic heart failure and/or arrhythmia of less than 3 months duration
• Endomyocardial biopsy diagnostic of idiopathic giant cell myocarditis
• Negative pregnancy test

Exclusion Criteria

• Clinical evidence of sepsis or active infection (e.g., meningitis or osteomyelitis)
• Pregnant
• Any contraindication to immunosuppression
• Allergy to cyclosporine or muromonab-CD3
• Creatinine greater than 2.5 mg/dL
• AST or ALT greater than 3 times upper limit of normal
• Other severe concurrent disease that would preclude study
• Unreliable or uncooperative subject

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Principal Investigators

Leslie T Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Rochester

Rochester, Minnesota, United States

Countries

United States

References

Cooper LT Jr, Hare JM, Tazelaar HD, Edwards WD, Starling RC, Deng MC, Menon S, Mullen GM, Jaski B, Bailey KR, Cunningham MW, Dec GW; Giant Cell Myocarditis Treatment Trial Investigators. Usefulness of immunosuppression for giant cell myocarditis. Am J Cardiol. 2008 Dec 1;102(11):1535-9. doi: 10.1016/j.amjcard.2008.07.041. Epub 2008 Sep 18.

Reference Type: DERIVED

PMID: 19026310 (View on PubMed)

Other Identifiers

FD-R-001986-0

Identifier Type: -

Identifier Source: secondary_id

FD-R-1986-01

Identifier Type: -

Identifier Source: org_study_id