Myocarditis Clinical Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05911386 -
Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases
|
||
Not yet recruiting |
NCT04085718 -
FDG-PET/CT Images Comparing to MRI and Endomyocardial Biopsy in Myocarditis
|
||
Enrolling by invitation |
NCT05610423 -
Covid-19 Vaccine Associated Myocarditis and Pericarditis in Norway
|
||
Active, not recruiting |
NCT05195645 -
AbataCept for the Treatment of Immune-cHeckpoint Inhibitors Induced mYocarditiS
|
Phase 2 | |
Recruiting |
NCT05184114 -
Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance
|
N/A | |
Recruiting |
NCT04612296 -
The Heart Hive - Cardiomyopathy Study
|
||
Recruiting |
NCT04673409 -
CMR Imaging of Autoimmune Diseases
|
||
Recruiting |
NCT05295290 -
A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
|
Phase 4 | |
Completed |
NCT03777839 -
PET-FDG in Myocarditis
|
||
Completed |
NCT06447935 -
Acute Eosinophilic Myocarditis International Registry
|
||
Not yet recruiting |
NCT05125965 -
Contribution of Cardiac MRI in the Early Diagnosis of Myocarditis Induced by Immunotherapy
|
N/A | |
Active, not recruiting |
NCT04444128 -
IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
|
||
Recruiting |
NCT06158698 -
CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine
|
Phase 3 | |
Recruiting |
NCT05282498 -
Pathophysiologic Mechanism for MYOcarditis in COVID19 VAccinations ("MYOVAx" Study)
|
||
Recruiting |
NCT05288426 -
Myocarditis Post Vaccination or Multi System Inflammatory Syndrome
|
||
Recruiting |
NCT03801681 -
ARrhythmias in MYocarditis
|
||
Recruiting |
NCT06116084 -
Randomized Controlled Study Evaluating the Efficacy of Hypnosis in Nuclear Medicine
|
N/A | |
Completed |
NCT04413071 -
Cardiac COVID-19 Health Care Workers
|
||
Recruiting |
NCT05414162 -
Multiparametric Cardiac MRI in Patients Under CAR T-cell Therapy
|
||
Recruiting |
NCT06409585 -
Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
|