Ireland
--:--IST
Recruiting Phase 3

MYTHS - MYocarditis THerapy With Steroids

NCT05150704 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2021-10-07
Last updated
2025-07-31

Condition(s) studied

Myocarditis Acute

Investigational drug(s) / intervention(s)

Methylprednisolone →saline solution

Methylprednisolone: Pulsed corticosteroid therapy (methylprednisolone 1 g IV qd for 3 days diluted in saline solution 250 mL) on top of standard therapy and maximal supportive care

saline solution: Placebo (saline solution 250 mL IV qd for 3 days) on top of standard therapy and maximal supportive care.

Study summary

This is a phase III, multi-center international, single blind randomized controlled trial to test the efficacy of pulsed intravenous (IV) methylprednisolone versus standard therapy on top of maximal support in patients with Acute myocarditis (AM).

Eligibility

Sex
ALL
Min age
18 Years
Max age
69 Years
Healthy volunteers
No
Inclusion Criteria: * 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 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 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); * 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; * 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.

Primary outcome measure(s)

  • 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.

Trial sites (49)

FacilityCityRegionStatus
University of California San Diego San Diego California Recruiting
University of Texas Houston Texas Not Yet Recruiting
University of Virginia Charlottesville Virginia Recruiting
Virginia Commonwealth University Richmond Virginia Not Yet Recruiting
Medical University of Graz Graz Austria Recruiting
Medical University Innsbruck Innsbruck Austria Not Yet Recruiting
Medical University of Wien Vienna Austria Recruiting
Onze Lieve Vrouwziekenhuis Aalst Belgium Recruiting
Antwerp University Hospital Edegem Belgium Recruiting
Jessa Hospital Hasselt Hasselt Belgium Recruiting
University Hospitals Leuven Leuven Belgium Recruiting
Masaryk University and St. Anne's University Hospital Brno Czechia Recruiting
Charles University in Prague and General University Hospital Prague Czechia Recruiting
Institute for Clinical and Experimental Medicine - IKEM Prague Czechia Recruiting
Heart and Lung Center, Helsinki University Hospital Helsinki Finland Not Yet Recruiting
AOU Ospedali Riuniti Umberto I°-Lancisi-Salesi di Ancona Ancona Italy Recruiting
ASST Papa Giovanni XXIII Bergamo Italy Recruiting
Policlinico S.Orsola-Malpighi Bologna Italy Recruiting
ASST Spedali Civili Brescia Italy Recruiting
Azienda Ospedaliera "G.Brotzu" Cagliari Italy Recruiting
P.O. SS. Annunziata Chieti -ASL 2 Abruzzo Chieti Italy Recruiting
Azienda Ospedaliero-Universitaria Careggi Florence Italy Recruiting
Ospedale Policlinico San Martino, IRCCS Genova Italy Recruiting
Azienda Socio-Sanitaria Territoriale (ASST) di Lecco Lecco Italy Recruiting
ASST Grande Ospedale Metropolitano Niguarda Milan Italy Recruiting
Centro Cardiologico Monzino Milan Italy Recruiting
ASST Monza, Ospedale San Gerardo Monza Italy Recruiting
Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi Naples Italy Recruiting
Azienda Ospedaliero Universitaria di Parma Parma Italy Recruiting
Fondazione IRCCS Policlinico San Matteo Pavia Italy Recruiting
Fondazione Toscana Gabriele Monasterio Pisa Italy Recruiting
Azienda Ospedaliera San Camillo Forlanini di Roma Roma Italy Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Italy Recruiting
Azienda Ospedaliera Universitaria Senese, Policlinico Santa Maria alle Scotte Siena Italy Recruiting
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Torino Italy Recruiting
Presidio Ospedaliero Universitario "Santa Maria della Misericordia" Udine Italy Recruiting
University Medical Centre Ljubljana Ljubljana Slovenia Recruiting
Complexo Hospitalario Universitario A Coruña (CHUAC) A Coruña Spain Recruiting
Bellvitge University Hospital Barcelona Spain Recruiting
Hospital de La Santa Creu I Sant Pau Barcelona Spain Recruiting

+ 9 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05150704 on ClinicalTrials.gov ↗ ← All trials in Italy