Pulse Corticosteroids Or/and Immunoglobulins to Treat Fulminant Myocarditis

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying new treatment options for a serious condition called fulminant myocarditis, which is a severe form of heart inflammation often triggered by viral infections. The researchers want to find out whether using corticosteroids (a type of anti-inflammatory medication) and intravenous immunoglobulin (a treatment made from donated blood that helps fight infections) can improve outcomes for patients with this condition. Fulminant myocarditis can lead to heart failure and requires immediate medical support, so the trial aims to provide clearer guidelines on how to manage this illness effectively.

To participate in the trial, patients must be adults with acute symptoms of fulminant myocarditis, including severe heart problems and elevated heart enzyme levels. They should also need short-term support for their heart function. Patients under 15 years old, pregnant women, and those with certain pre-existing health conditions are not eligible. Participants will receive one of the study treatments and will be monitored closely by medical professionals throughout the trial. It’s important to note that the trial is not yet recruiting participants, so there will be more information available once it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Fulminant myocarditis defined by
• • the acute illness (\<1 month from symptom onset),
• • hemodynamic compromise due to cardiogenic shock (confirmed by echocardiography) or electrical storm,
• • elevated plasma cardiac troponin \> twice normal value
• • need for hemodynamic support (inotropes or temporary mechanical circulatory support) for less than 72 hours in the absence of an ischemic cause or other pre-existing cardiomyopathies Noticeably, a coronary angiogram should be performed in patients ≥40 years of age when myocarditis has not been proven histologically. Besides, an endomyocardial biopsy will not be mandatory to fulfill the definition of fulminant myocarditis.
• • 2. Signed informed consent from the patient, a close relative or surrogate or a family member or a legal representative for minor patient.
• • Adult : According to the specifications of emergency inclusion, randomization without the close relative/surrogate consent could be performed if the patientis unable to give his/her consent and when the close relative/surrogate/family member are absent. Close relative/surrogate/family member consent will be asked as soon as possible after randomization. The patient will be asked as soon as possible to give his/her consent for the continuation of the trial when his/her condition will allow.
• • Minor : According to the specifications of emergency inclusion, randomization could be performed when legal representative are absent. Legal representative consent will be asked as soon as possible after randomization 3. Social security registration (AME excluded)
• Exclusion Criteria:
• • 1. Age \<15 2. Pregnancy or breastfeeding or baby delivery \<6 months 3. Initiation of inotropes or temporary mechanical circulatory support \>72 hours 4. Resuscitation \>20 minutes (cumulative low-flow time \> 20 minutes ) 5. Pre-existing ischemic or dilated cardiomyopathy or Tako-Tsubo evaluated by echocardiography.
• • 6. Known systemic autoimmune disorder or other conditions requiring immunosuppression 7. Patients with peripheral eosinophilia (≥1000 G/L) 8. Myocarditis associated with anti-cancer immune checkpoint inhibitor agents 9. Active severe bacterial or fungal infectious disease 10. Patient moribund on the day of randomization, SAPS II \>90 11. Contraindication or allergies to corticosteroids or immunoglobulins or any components of the formulations or their excipients 12. Patients already on corticosteroids or receiving IVIG 13. Participation in another interventional study or being in the exclusion period at the end of a previous study.
• • 14. Patients with an uncontrolled psychotic condition Patients with known anti-IgA antibodies in line with the contraindications of methylprednisolone IV and of IVIg based products respectively