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Corticoid Therapy in Acute Myocarditis
EU CTIS ID: 2024-510602-90-00
What this study is testing
To evaluate in patients with acute myocarditis and left-ventricular dysfunction the efficacy of a pulse of Methylprednisolone IV for 3 days at diagnosis followed by Prednisone per os versus placebo IV followed by placebo per os in association with conventional HF therapy on the occurrence of Major Cardiovascular Events (MACE) and/or persistence of left ventricular dysfunction defined as LVEF < 50% and/or Global Longitudinal Strain (GLS) < -16% between baseline (D-2) and at 6 months (M6).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Written signed informed consent
- Affiliation to the French health care system (Sécurité Sociale) or to another social protection scheme with the exception of State Medical Aid (Aide Médicale de l’Etat AME)
- Active myocarditis defined by (all items are required): 1- Chest pain and/or 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), 2- And troponin rise (1,5 times the normal range) and 3- 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
You likely can't join if
- Active coronary disease
- 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
- Contra-indication linked to auxiliary drugs according to respective SmPC
- Patient deprived of liberty or under Curatorship/Tutorship, safeguard of justice, according to French law
See the full eligibility criteria
- Age ≥ 18 years
- Written signed informed consent
- Affiliation to the French health care system (Sécurité Sociale) or to another social protection scheme with the exception of State Medical Aid (Aide Médicale de l’Etat AME)
- Active myocarditis defined by (all items are required): 1- Chest pain and/or 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), 2- And troponin rise (1,5 times the normal range) and 3- 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
- Active coronary disease
- 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
- Contra-indication linked to auxiliary drugs according to respective SmPC
- Patient deprived of liberty or under Curatorship/Tutorship, safeguard of justice, according to French law
- According to the opinion of the investigator, foreseeable inability to respect the protocol (understanding of research, ability to go to hospital, ability to take oral treatment, etc.
- 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 SmPC: 1- Any infectious condition excluding the specified therapeutic indications of Methylprednisolone and Prednisone, 2- Certain evolving viruses (notably hepatitis, herpes, chickenpox, shingles), 3- Psychotic states not yet controlled by treatment, 4- 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), 5- Hypersensitivity to the active substances or to any of the excipients
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.