MYTHS: Myocarditis Therapy With Steroids

This study, called MYTHS, is looking at whether a steroid medication called methylprednisolone can help people with acute myocarditis (inflammation of the heart muscle). You might be able to join if you are 18-69 years old, are in the hospital for suspected acute myocarditis, and have certain levels of heart-related biomarkers (NT-proBNP or BNP). Participants will receive either methylprednisolone or a placebo (saline solution) in addition to their usual care. The researchers will be looking to see if this treatment can reduce serious events like death, heart transplant, or rehospitalization due to heart failure within six months.

Study design: This is a phase III, international, single-blind (you won't know if you're getting the study drug or placebo) randomized controlled trial aiming to enroll 288 participants.
What's involved: Participants will receive either methylprednisolone or saline solution intravenously (IV) once a day for three days.
Compensation: Not stated in the trial record.
Follow-up: The study will track your health for six months after you join to see if certain events occur.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

MYTHS - MYocarditis THerapy With Steroids

Recruiting

PHASE3Ages 18–69InterventionalTreatment

Niguarda Hospital

~288 participants

Updated 2025-07-31 on ClinicalTrials.gov

What's tested:Methylprednisolonesaline solution

At a glance

Recruiting sites

42 of 49 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Time from randomization to the first event among: all-cause death, HTx, long-term LVAD implant, need for an upgrading of the t-MCS, VT/VF treated with DC shock, first rehospitalization due to HF or ventricular arrhythmias, or AV block.

Measured over 6 months from patients enrollment

Conditions

Myocarditis Acute

Where it's being run

49 sites across 11 states

Italy21

Spain9

Belgium4

Austria3

Czechia3

Sweden3

Virginia2

California1

Who to contact

Enrico Ammirati, MD, PhD

[email protected]

+39 0264447791

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients admitted to hospital for suspected AM

Age 18 years or older and below 70 years (18-69 years)

Acute HF with clinically suspected acute myocarditis based on 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;

Left ventricular ejection fraction (LVEF)\<41% and left ventricular end diastolic diameter (LV-EDD)\<56 mm (parasternal long-axis view) on echocardiogram;

Increased troponin (3x upper reference limit \[URL\]) 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.

Exclusion

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 giant cell myocarditis (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 of a systemic autoimmune disorder, or cardiac sarcoidosis or GCM;

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 endomyocardial biopsy (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 disease (i.e., previous cardiomyopathy) that does NOT include previous myocarditis if there is a functional recovery at the time of screening);

Known chronic infective disease, such as HIV infection or tuberculosis;

out-of-hospital cardiac arrest;

t-MCS instituted more than 48 hours before randomization;

Patients clinically judged too sick to initiate t-MCS (i.e., irreversible multiorgan failure);

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.

What this trial measures

Time from randomization to the first event among: all-cause death, HTx, long-term LVAD implant, need for an upgrading of the t-MCS, VT/VF treated with DC shock, first rehospitalization due to HF or ventricular arrhythmias, or AV block.6 months from patients enrollment
The Primary composite endpoint is defined as the time from randomization to the first event occurring within 6 months on patients treated with pulsed corticosteroid therapy vs. standard therapy and maximal supportive care, among: (1) all-cause death, or (2) heart transplantation (HTx), or (3) long-term left ventricular assist device (LVAD) implant, or (4) need for an upgrading of the t-MCS, or (5) a ventricular tachycardia (VT)/fibrillation (VF) treated with direct current (DC) shock (excluding VT/VF in patients on t-MCS other than IABP), or (6) first rehospitalization due to HF or ventricular arrhythmias, or advanced Atrioventricular (AV) block.

Trialytics