Myocarditis Therapy with Steroids in patients with a Mildly Reduced ejection fraction (MYTHS-MR)

Phase 1

• Conditions: Acute myocarditis; MedDRA version: 20.0Level: PTClassification code: 10028606Term: Myocarditis Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code: 10031516Term: Other and unspecified acute myocarditis Class: 10007541; MedDRA version: 20.0Level: PTClassification code: 10064550Term: Myocarditis post infection Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code: 10028619Term: Myocarditis unspecified Class: 10007541; MedDRA version: 20.0Level: LLTClassification code: 10028618Term: Myocarditis viral NOS Class: 10021881; MedDRA version: 20.0Level: LLTClassification code: 10000934Term: Acute myocarditis unspecified Class: 10007541; MedDRA version: 20.0Level: LLTClassification code: 10021234Term: Idiopathic myocarditis Class: 10007541; MedDRA version: 20.0Level: LLTClassification code: 10000932Term: Acute myocarditis Class: 10007541; MedDRA version: 20.0Level: HLTClassification code: 10029548Term: Noninfectious myocarditis Class: 10007541

• Registration Number: CTIS2022-501547-33-01
• Lead Sponsor: Antwerp University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

Age 18 years or older and below 70 years (18-69 years), LVEF<50% and LV-EDD<56 mm (parasternal long-axis view) on echocardiogram, Increased troponin (3x URL) at the time of randomization, Clinically suspected myocarditis with 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, Patient has voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC) or institutional review board (IRB), after the nature of the study has been explained and the patient has had the opportunity to ask questions.

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, Myocarditis associated with the ongoing administration of anti-cancer immune checkpoint inhibitor (ICI) agents, Previously known chronic cardiac disease, 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 before randomisation, Contraindication for CMRI, 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)., Patients already on oral/IV chronic corticosteroid therapy or other chronic immunosuppressive therapies, Contraindication to corticosteroids, including history of previous (steroid) psychosis, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified