Corticoid Therapy in Acute Myocarditis (NCT06522100) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Corticoid Therapy in Acute Myocarditis
420 participantsStarted 2025-02-01
Plain-language summary
Refer to the "Detailed Description" section.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years
* Written signed informed consent
* Affiliation to the French health care system or to another social protection scheme with the exception of State Medical Aid
* Active myocarditis defined by (all items are required):
* Acute chest pain and/or unexplained heart failure and/or syncope and/or sustained ventricular arrhythmias and/or aborted sudden death and/or cardiogenic shock and/or ECG modification (atrioventricular block or bundle branch block or sinus arrest or ST or T waves change or ventricular arrhythmia or atrial fibrillation or abnormal Q waves)
* And troponin rise (1,5 times the normal range)
* And diagnosis of active myocarditis on Cardiac Magnetic Resonance (according to Lake-Louise criteria) or by histological evidence on endomyocardial biopsy (Dallas's criteria)
* Left-ventricular dysfunction defined as LVEF \< 50% and/or GLS \< -16% assessed with 2D-TTE
* Normal coronary angiography or CT Scan (without stenosis \> 50%) during the previous year
Exclusion Criteria:
* Active coronary disease
* Other causes of chronic heart failure (coronary artery disease, primary valvular heart disease, congenital heart disease)
* Other etiology of myocarditis requiring corticosteroids treatment as giant cells myocarditis, eosinophilic myocarditis and cardiac sarcoidosis or immune checkpoint inhibitor myocarditis
* Other auto-immune or inflammatory disease requiring corticosteroids treatment within 6 months before enrolment
* Pregnanc…