Status:
NOT_YET_RECRUITING
Corticoid Therapy in Acute Myocarditis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Myocarditis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Refer to the "Detailed Description" section.
Detailed Description
Introduction: Acute myocarditis (AM) is an inflammatory disease of the heart. The incidence is approximately 22 out of 100 000 patients annually. Clinically, it ranges from subclinical pauci-symptomat...
Eligibility Criteria
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
- 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
- Pregnancy or breastfeeding
- 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)
- 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
- 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.
- Any medical and/or cognitive condition which limits the ability of participant to participate in study
- 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)
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 16 2028
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT06522100
Start Date
February 1 2025
End Date
August 16 2028
Last Update
July 29 2024
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