NCT06896253

Pulse Corticosteroids Or/and Immunoglobulins to Treat Fulminant Myocarditis

Pulse Corticosteroids Or/and Immunoglobulins to Treat Fulminant Myocarditis: a Double-blind Randomized Controlled Adaptive Trial the CORIUM Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Fulminant myocarditis (FM) is the most severe manifestation of acute myocarditis, an acute inflammatory myocardial disease most often triggered by viral infections. Currently, the most accepted definition of FM requires acute illness, hemodynamic compromise due to cardiogenic shock, and need for hemodynamic support (inotropes and/or temporary mechanical circulatory support (t-MCS) in the absence of an ischemic cause or other pre-existing cardiomyopathies. Unfortunately, there is a paucity of evidence-based management strategies for this disease and the management of patients affected by FM often varies according to local experience and practice with the role of immunosuppression being the most debated issue. Besides, due to inconsistent results obtained in several studies and frequent spontaneous recovery with supportive therapy alone, immunosuppression is largely debated in the setting of lymphocytic myocarditis (LM). Among available medications for this disease, corticosteroids are often used despite a lack of clear evidence in the context of FM. Similarly, intravenous immunoglobulin (IVIG) has both antiviral and anti-inflammatory effects on myocarditis. In adults, a recent meta-analysis based on case series showed that IVIG therapy significantly reduced in-hospital mortality, improved the left ventricular ejection fraction, and significantly increased the survival rate in patients with FM. More recently, FM among patients with COVID-19, including post-infectious multisystem inflammatory syndrome, has been reported in young adult patients. These severe forms have been successfully treated with intravenous corticosteroids and IVIG, highlighting the relevance of the systemic inflammatory response in determining cardiac injury in COVID-19, even though more evidence is needed.

Conditions

• Myocarditis Acute

Interventions

Type	Name	Description
DRUG	Pulse bolus corticosteroids	Treatment administration
DRUG	Pulse bolus corticosteroids and IVIG	Treatment administration
DRUG	Pulse bolus corticosteroids (G5%) and IVIG (G5 %)	Treatment administration

Timeline

• Start date: 2025-04-01
• Primary completion: 2029-05-01
• Completion: 2029-11-01
• First posted: 2025-03-26
• Last updated: 2025-03-26