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Pulse corticosteroids or/and Immunoglobulins to treat fulminant Myocarditis: a double-blind randomized controlled adaptive trial (The CORIUM study)
EU CTIS ID: 2023-506599-28-01
What this study is testing
To assess at day 28 the efficacy of pulse bolus corticosteroids or pulse bolus corticosteroids and IVIG vs double placebo on a composite hierarchical outcome of mortality or heart transplantation/ long-term ventricular assist device (VAD)/persisting t-MCS and the number of days alive between randomization and day 28 without t-MCS and inotropes.
- Therapeutic exploratory (Phase II)
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
- 1. Fulminant myocarditis defined by • the acute illness (<1 month from symptom onset), • hemodynamic compromise due to cardiogenic shock 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)
You likely can't join if
- 1. Age <15
- 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.
- 2. Pregnancy or breastfeeding or baby delivery <6 months
See the full eligibility criteria
- 1. Fulminant myocarditis defined by • the acute illness (<1 month from symptom onset), • hemodynamic compromise due to cardiogenic shock 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)
- 1. Age <15
- 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.
- 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
- 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
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.