Treatment of acute myocarditis with corticosteroids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy of pulsed intravenous methylprednisolone compared to standard therapy in patients with acute myocarditis and mildly reduced left ventricular ejection fraction (LVEF). Participants will be randomly assigned to receive either the corticosteroid treatment or standard care, with the primary outcomes being improvements in LVEF and reductions in adverse cardiac events over a six-month period. The study aims to determine if corticosteroids can effectively reduce myocardial inflammation and improve heart function in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* LVEF\<50% and LV-EDD\<56 mm (parasternal long-axis view) on echocardiogram;
* Increased troponin (3x URL) at the time of randomization;
* Clinical onset of cardiac symptoms within 3 weeks from randomization;
* Excluded coronary artery disease by coronary angiogram in subjects ≥46 years of age, in case myocarditis is not histologically proven;
* Randomization within 120 hours from hospital admission.
* Endomyocardial biopsy (EMB) is not considered necessary before randomization and performing EMB is based on the decision of the local team.

Exclusion Criteria:

* Known systemic autoimmune disorder or other conditions at the time of randomization where immunosuppression is assumed useful. Patients in whom a systemic autoimmune disorder will be diagnosed during hospitalization will be included in the study if randomized, including patients with a diagnosis of cardiac sarcoidosis or GCM). Both patients included in the corticosteroids-treatment arm or in the placebo-treatment arm can receive the standard immunosuppressive therapy used in the center since the diagnosis;
* Patients already on oral/IV chronic corticosteroid therapy or other chronic immunosuppressive therapies (colchicine or nonsteroidal anti-inflammatory drugs \[NSAIDs\] are not considered immunosuppressive drugs);
* Contraindication to corticosteroids, including allergies to this medication and its excipients;
* Patients with persistent peripheral eosinophilia (persistent eosinophil count \>7% of the leukocytes) or known hypereosinophilic syndrome at the time of randomization. Patients in whom eosinophilic myocarditis will be diagnosed on EMB will be included in the study if already randomized. Both patients included in the corticosteroids-treatment arm or in the placebo-treatment arm can receive the standard immunosuppressive therapy used in the center since the diagnosis;
* Myocarditis associated with the ongoing administration of anti-cancer immune checkpoint inhibitor (ICI) agents;
* Previously known chronic cardiac (i.e., previous cardiomyopathy, that does NOT include previous myocarditis if there is a functional recovery at the time of screening);
* Evidence of active bacterial or fungal infectious disease (presence of fever or increased C-reactive protein are not considered exclusion criteria), or suspected bacterial/fungal infection associated with increased levels of procalcitonin (cut-off \>10 ng/mL), if the laboratory exam is available in the center;
* Known chronic infective disease, such as HIV infection or tuberculosis;
* Out-of-hospital cardiac arrest;
* Echocardiographic presence of images suggestive of other cardiac diseases (i.e. endocarditis)
* Participants involved in another clinical trial;
* Pregnant women (known pregnancy) or POSITIVE human chorionic gonadotropin (HCG) test measures (urine/blood) for women of 18-50 years of age.
* Any other significant disease with expected life expectancy \<12 months (i.e., evidence of irreversible severe brain injury) or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* If LVEF\<41%, an N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration of 1600 pg/mL or more or a B-type natriuretic peptide (BNP) concentration of 400 pg/mL or more; (if LVEF 41%-\<50% any NT-proBNP or BNP concentration is allowed).

Where it's running

• Antwerp University Hospital
  Edegem, Antwerp, Belgium Recruiting
• Onze-Lieve-Vrouwziekenhuis (OLV ziekenhuis)
  Aalst, Belgium Recruiting
• Middelheim Ziekenhuis
  Antwerp, Belgium Recruiting
• Jessa ziekenhuis
  Hasselt, Belgium Recruiting
• Universitair ziekenhuis Leuven
  Leuven, Belgium Recruiting
• Niguarda Hospital
  Milan, Milan, Italy Recruiting

Study contacts

• Principal investigator: Caroline Van de Heyning — University Hospital, Antwerp
• Study coordinator: Caroline Van De Heyning, MD PhD
• Email: caroline.vandeheyning@uza.be
• Phone: +32 821 3538

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.