Corticoid Therapy in Acute Myocarditis
Key facts
- Phase
- Phase 3
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT06522100EU 2024-510602-90-00
- Record updated
- 29 July 2024
- Original description
Refer to the "Detailed Description" section.Read full original descriptionShow less
Use of Glucocorticoids Therapy in Acute Myocarditis With Severe Left Ventricular Dysfunction: a Multicenter Randomized Controlled Trial
Refer to the "Detailed Description" section.
Inclusion: 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: Other auto-immune or inflammatory disease requiring corticosteroids treatment within 6 months before enrolment; Concomitant participation in another clinical trial on medical product for human use, to a clinical investigation on a medical device, to interventional study involving human participants or in the exclusion period at the end of a previous clinical trial on medical product for human use, a clinical investigation on a medical device, or study involving human participants. Participation in non-interventional research is permitted; Contra-indication linked to steroids (Methylprednisolone and Prednisone) according to summary of product characteristics:; Any infectious condition excluding the specified therapeutic indications of Methylprednisolone and Prednisone; Certain evolving viruses (notably hepatitis, herpes, chickenpox, shingles); Psychotic states not yet controlled by treatment; Recent live vaccines or live attenuated vaccines in patients receiving dosages greater than 20 mg/day of prednisone equivalent for more than two weeks and during the 3 months following the cessation of corticosteroid therapy (risk of generalized vaccine disease possibly fatal); Hypersensitivity to the active substances or to any of the excipients; Contra-indication linked to auxiliary drugs according to respective summary of product characteristics:; Beta-blockade; Angiotensin-converting-enzyme inhibitor (ACE-I); Angiotensin receptor blockers (ARB); Mineralocorticoid antagonists (MRA); Angiotensin receptor-neprilysin inhibitor (ARNi); 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; Woman of childbearing potential without effective method of birth control (included contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices); Any medical and/or cognitive condition which limits the ability of participant to participate in study; Pregnancy or breastfeeding; Patient deprived of liberty or under Curatorship/Tutorship, safeguard of justice, according to French law; Foreseeable inability, according to the investigator, to participate in all the visits, treatments and measures provided for in the protocol; Patient not speaking or understanding French.