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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00027443
Collaborator
(none)
40
Enrollment
1
Location
71
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Giant Cell Myocarditis Treatment Trial Pilot Study
Study Start Date :
Aug 1, 2001
Study Completion Date :
Jul 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Leslie T Cooper, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00027443
    Other Study ID Numbers:
    • FD-R-1986-01
    • FD-R-001986-0
    First Posted:
    Dec 7, 2001
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Oct 1, 2001
    Keywords provided by , ,
    Giant Cell Myocarditis
    Additional relevant MeSH terms:
    Myocarditis
    Cyclosporine
    Cyclosporins
    Muromonab-CD3

    Study Results

    No Results Posted as of Mar 25, 2015