CardiomyopathyUsefulness of Immunosuppression for Giant Cell Myocarditis
Section snippets
Methods
The initial design of the study was a multicenter, randomized, open-label, 2-arm trial and parallel prospective treatment registry. The active treatment group received 10 days of muromonab-CD3 and 1 year of cyclosporine and steroids as described later. The control group received “usual care” that could include no immunosuppression or steroids and/or azathioprine at the discretion of the site principal investigator. A prospective treatment registry was an option for subjects who declined to be
Results
The clinical performance sites and principal investigators that participated in study enrollment are listed in the Appendix. Participation is defined as having Institutional Review Board approval for the study and all required contractual and regulatory documentation necessary for screening and enrollment. Enrollment refers to subjects with GCM who signed consent.
A total of 28 subjects signed consent for screening before endomyocardial biopsy. Of these 28 screened subjects, 8 subjects (29%) had
Discussion
Several observations in this study add meaningfully to the very limited knowledge regarding GCM treatment. First, immunosuppressive treatment with the combinations of agents used in this study resulted in relatively low 1-year mortality. Further, abrupt withdrawal of immunosuppression can result in recurrent, fatal GCM. Finally, the rate of adverse events probably has an acceptable safety profile in this high-risk population.
We observed a marked improvement in the inflammatory infiltrate
Acknowledgment
We especially thank Adita Mascaro-Blanco for performing the anti-HCM, anti-β1 and anti-β2 ELISAs in this study.
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This work was supported by US Food and Drug Administration Grant FD-RO-1-001986 and a Leder Family Philanthropic Grant, Washington, DC. Muromonab-CD3 was supplied by Ortho-Biotek, Inc.
Clinical Trial Registration NCT00027443 (http://www.clinicaltrials.gov/ct/show/NCT00027443?order=1).