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RecruitingNCT05150704MYTHSUpdated Jul 31, 2025

MYTHS - MYocarditis THerapy With Steroids

A Phase 3 interventional study of Methylprednisolone and saline solution in Myocarditis Acute, sponsored by Niguarda Hospital. Recruiting at 49 sites in 9 countries. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2025-07-31.

Sponsored by Niguarda Hospital · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2021; still recruiting 5 years 1 month later.
Phase
Phase 3
Study type
Interventional
Enrollment
288
Allocation
Randomized
Ages
18 Years to 69 Years
Sex
All
01

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).

Read the detailed description

Acute myocarditis (AM) is a common condition characterized by histological evidence of inflammatory infiltrates associated with myocyte necrosis of non-ischemic origin. Clinical presentation spans from indolent form to cardiogenic shock also called fulminant myocarditis (FM). Patients can be stratified on the basis of their clinical presentation: patients with left ventricular (LV) ejection fraction (EF)\<50% at first echocardiogram, and those with sustained ventricular arrhythmias, called complicated AM, have a worse prognosis compared with uncomplicated cases with preserved left ventricular ejection fraction (LVEF) and without arrhythmias. Among complicated AM, FM patients are those ones at the highest risk, presenting with severely impaired LVEF (generally \<40%), and with need for inotropes and/or temporary mechanical circulatory supports (t-MCS).The pathogenesis of AM is felt to be due to an immune-mediated response against the myocardium.

As such, the overall objective is to evaluate the efficacy of pulsed IV corticosteroids therapy for the treatment of AM. It is proposed to test the efficacy of pulsed IV methylprednisolone in a single blind randomized controlled trial versus standard therapy on top of maximal support. The rationale for using pulsed corticosteroid therapy in the acute setting (within 3 weeks from cardiac symptoms' onset) to reduce myocardial inflammatory infiltrates favoring recovery appears strong. Nevertheless, no trial has tested this hypothesis in the very acute phase of AM, despite the high mortality rate of this condition and the fact that AM mainly affects young patients.

Currently, no specific medications in the acute phase of lymphocytic AM are recommended beyond supportive therapy with inotropes and t-MCS. One Cochrane review on corticosteroids showed that almost all studies focused on inflammatory cardiomyopathies with 6 months of symptoms of heart failure (HF), and despite an improvement of cardiac function observed in low quality and small size studies, there was no improvement in the survival. In the past, only one study assessed the efficacy of immunosuppression in AM, the Myocarditis Treatment Trial (MTT) that reported no benefit from immunosuppression. Neutral results in the MTT could be ascribed to a delay in the initiation of this potentially effective treatment. Thus, 55% of patients started immunosuppressive therapy after 1 month from the onset of myocarditis, when the left ventricle (LV) was already dilated, as highlighted by a mean LV end-diastolic diameter (EDD) of 64 mm. It is expected that patients with FM have normal LV dimension during the acute phase despite severe LV systolic dysfunction. Based on a study from PI group, it was observed that FM patients recover most of the LVEF in the first 2 weeks after admission, with a median absolute increase of 30%. This finding further suggests that an immunosuppressive treatment should be started as soon as possible to demonstrate effectiveness. As little has changed in the medical treatment of this condition in the last 30 years, identification of effective drugs is needed.

Patients admitted to hospital for suspected AM complicated by acute HF/cardiogenic shock and LV systolic dysfunction will be screened for randomization.

Patients will be randomized in the two arms in a 1:1 ratio (Pulsed methylprednisolone therapy vs Placebo). Randomization will be performed with stratification by country.

The primary objective is to demonstrate a reduction in the rate of the primary composite endpoint on patients treated with pulsed methylprednisolone therapy vs. standard therapy and maximal supportive care.

Endpoints will be analyzed according to the following principles:

  • Intention-to-treat (ITT) population
  • Per Protocol (PP) population:
  • "Safety population"
  • A sensitivity analysis will also be performed on the previously defined populations after excluding patients (1) with histological diagnosis of giant cell myocarditis (GCM) or (2) who did not reach the final diagnosis of acute myocarditis based on CMRI or histology.

Sample size calculation: we plan to recruit a total of 360 patients, and we expect that about 20% of these patients or local physicians will refuse randomization. This would leave a total of 288 randomized patients (144 per arm).

Considering as relevant a reduction in the probability to reach the primary endpoint at 6 months from 25% in the standard therapy on top of maximal supportive care arm to 12% in the pulsed corticosteroid therapy arm (absolute risk reduction of 13% in absolute corresponding to a hazard ratio (HR) pulsed corticosteroid therapy vs. standard therapy of 0.44), the planned sample size will allow achieving a power of 0.80 with a one-sided log-rank test and an overall type I error of 0.025. The 25% figure considered for the standard therapy derives from a retrospective analysis of the patient's cohort spanning over 20 years. The calculation includes an interim analysis planned at 50% recruitment (O\'Brien-Fleming method). This interim analysis is accounted for in the sample size calculation with an alpha level of 0.001525 (final analysis 0.023475 alpha level) and is planned on the primary endpoint to assess a possible early treatment effect. No specific stopping rules are planned, given the multiplicity of aspects involved, but the report on safety will be reviewed by the Data and Safety Monitoring Committee (DSMC) will advise on possible aspects of the trial that need reconsideration.

Sample size adaptation: We will consider, based on the DSMC advise an adaptive approach to sample size in two regards:

  1. At the interim analysis, if the baseline incidence is lower than the expected 25%, the sample size calculation may be re-evaluated keeping the same HR of 0.44. For instance, if the observed incidence is 20%, maintaining the same HR of 0.44 (corresponding to an incidence of 9% in the pulsed corticosteroid therapy group, i.e. 11% in absolute risk reduction) the effective sample size needed to achieve 80% power should be increased to 360 patients. If the baseline incidence is higher than 25%, the planned actual sample size will achieve a power greater than 80% to detect a HR of 0.44 and no action will be taken.
  2. Based on the conditional power method, and on the DSMC advise, we may reconsider if a less promising result than HR=0.4444 is worth pursuing, given the current observed estimate. This case would require an increase in sample size that will be discussed in terms of relevance and feasibility. For example, if at the planned interim analysis, the estimated absolute risk reduction is at least 10% (HR=0.56) with 25% baseline, and the conditional power of meeting this 10% target (instead of the planned 13%) would be at least 60%, the sample size may be increased to reach the 80% desired power. In this case, the final effective sample size should be increased to 254 patients per arm to preserve an 80% power of demonstrating the less marked difference. The flexibility allowed in the sample size estimate will be considered based on the evaluation of the interim report by the DSMC and no data will be disclosed on interim treatment estimates to the study coordinator and steering committee.

The overall duration of the study from first patient first visit to last patient last visit will be 39 months. The follow-up will be up to 6 months and with additional 3 months to lock the database. Enrollment will last 30 months.

In parallel, there will be a prospective registry of patients that are eligible for the trial, but they are not randomized.

A second registry, called MYOCARDITIS REGISTRY will prospectively recruit all patients with acute myocarditis demonstrated by CMRI or EMB who are not eligible for randomization (not all centers will take part in this registry).

The study is supported by a grant from Italian Ministry of Health (GR-2019-12368506) and Lombardy Region.

Exemption from the investigational new drug (IND) regulations by FDA on August 2nd, 2021 (PIND: 15727)

EudraCT identifier: 2021-000938-34

02

Conditions studied

  • Myocarditis Acute

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Keywords

  • Acute Myocarditis
  • Corticosteroid therapy
  • Myocarditis
  • Trial
  • Immunosuppression
  • Acute heart failure
  • Fulminant acute myocarditis
03

In context

Myocarditis

174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.

This study's planned enrollment of 288 is above the median of 80 across 53 interventional studies indexed under Myocarditis.

Browse Myocarditis studies →

Lead sponsor

Niguarda Hospital is the lead sponsor of 68 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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;
  • (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 proven;
  • Randomization within 120 hours from hospital admission.

Exclusion criteria

Exclusion Criteria:

  • Known systemic disorder or other conditions at the time of randomization where 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 -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);
  • to corticosteroids, including allergies to this medication and its ;
  • 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 (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 (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 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 \<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.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
288 participants (estimated)

Study arms

  • Experimental
    Experimental arm

    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

    Drug: Methylprednisolone

  • Placebo comparator
    Control arm

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

    Drug: saline solution

Interventions

  • DrugMethylprednisolone

    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

  • Drugsaline solution

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

06

What researchers measure

Primary outcomes

  1. 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.

    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.

    Time frame: 6 months from patients enrollment

Secondary outcomes

  1. Time from randomization to the first event among: all-cause death, HTx, long-term LVAD implant, first rehospitalization due to HF or ventricular arrhythmias, or advanced AV block.

    The main secondary composite endpoint is defined as the time from randomization to the first event occurring within 6 months on patients treated pulsed corticosteroid therapy vs. standard therapy and maximal supportive care, among: (1) all-cause death or (2) HTx or (3) long-term LVAD implant or (4) first rehospitalization due to HF or ventricular arrhythmias, or advanced AV block.

    Time frame: 6 months from patients enrollment

  2. Mortality

    Time from randomization to all-cause death within 6 months.

    Time frame: 6 months from patients enrollment

  3. Proportion of patients who experience at least one of the following events during index hospitalization: (1) all-cause death, or (2) HTx, or (3) long-term LVAD implant, or (4) need for an upgrading of the t-MCS, or (5) a VT/VF treated with DC shock

    In-hospital composite endpoint is defined as the proportion of patients who experience at least one of the following events during index hospitalization: (1) all-cause death, or (2) HTx, or (3) long-term LVAD implant, or (4) need for an upgrading of the t-MCS, or (5) a VT/VF treated with DC shock (excluding VT/VF in patients on t-MCS other than IABP).

    Time frame: 6 months from patients enrollment

  4. Number of days on t-MCS from randomization

    Number of days on t-MCS from randomization

    Time frame: 6 months from patients enrollment

  5. Number of days in ICU from randomization

    Number of days in ICU from randomization

    Time frame: 6 months from patients enrollment

  6. Change in LVEF on echocardiogram after 5 days from randomization

    Change in LVEF on echocardiogram after 5 days from randomization

    Time frame: 5 days from randomization

  7. Change of troponin levels after 5 days from randomization

    Change of troponin levels after 5 days from randomization (ratio of troponin level/local troponin URL).

    Time frame: 5 days from randomization

  8. Change in heart rate (HR) on ECG after 3 days from randomization

    Change in heart rate (HR) on ECG after 3 days from randomization (ECG recorded at the hour of initial randomization

    Time frame: 3 days from randomization

  9. Proportion of patients with LVEF<55% AND/OR LV dilation on 6-month cardiac magnetic resonance imaging (CMRI)

    Proportion of patients with LVEF\<55% AND/OR LV dilation on 6-month cardiac magnetic resonance imaging (CMRI)

    Time frame: 6 months from patients enrollment

  10. Proportion of patients with LVEF<55% on 6-month CMRI

    Proportion of patients with LVEF\<55% on 6-month CMRI

    Time frame: 6 months from patients enrollment

  11. Proportion of patients with LV dilation on 6-month CMRI

    Proportion of patients with LV dilation on 6-month CMRI

    Time frame: 6 months from patients enrollment

Other outcomes

  1. Safety endpoints

    * Incidence of serious infections within 6 months; * Incidence of infections needing an IV therapy, excluding prophylactic antibiotic therapy within 6 months; * Incidence of upper gastrointestinal bleeding needing therapeutic endoscopy to achieve acute hemostasis; * Acute psychosis leading to the use of neuroleptic agents; * Incidence of critical illness myopathy or/and polyneuropathy (CIM/CIP); * Incidence of aseptic necrosis of femoral and humeral heads; * Incidence of stroke; * Incidence of need for pace-maker (both temporary and permanent); * Incidence of need for pericardiocentesis; * Incidence of need for mechanical ventilation after randomization; * Incidence of need for continuous venovenous hemofiltration (CVVH); * Incidence of bleeding requiring ≥5 units of blood or packed red blood cells.

    Time frame: 6 months from patients enrollment

07

Study locations

42 of 49 sites recruiting
  • University of California San Diego
    San Diego, California 92093, United States
    Recruiting
    • Eric D Adler, MD · Contact
  • University of Texas
    Houston, Texas 77204, United States
    Not yet recruiting
    • Angelo Nascimbene, MD · Contact
  • University of Virginia
    Charlottesville, Virginia 22903, United States
    Recruiting
    • Antonio Abbate, MD · Contact
  • Virginia Commonwealth University
    Richmond, Virginia 23284, United States
    Not yet recruiting
    • Roshanak Markley, MD · Contact
  • Medical University of Graz
    Graz, Austria
    Recruiting
    • Markus Wallner, MD · Contact
  • Medical University Innsbruck
    Innsbruck, Austria
    Not yet recruiting
    • Gerhard Poelzl, MD · Contact
  • Medical University of Wien
    Vienna, Austria
    Recruiting
    • Max Lenz, MD · Contact
  • Onze Lieve Vrouwziekenhuis
    Aalst, Belgium
    Recruiting
    • Mark Heggermont, MD · Contact
  • Antwerp University Hospital
    Edegem, Belgium
    Recruiting
    • Caroline Van De Heyning, MD · Contact
  • Jessa Hospital Hasselt
    Hasselt, Belgium
    Recruiting
    • Philippe Jr Timmermans, MD · Contact
  • University Hospitals Leuven
    Leuven, Belgium
    Recruiting
    • Walter Droogné, MD · Contact
  • Masaryk University and St. Anne's University Hospital
    Brno, Czechia
    Recruiting
    • Jan Krejčí, MD · Contact
  • Charles University in Prague and General University Hospital
    Prague, Czechia
    Recruiting
    • Petr Kuchynka, MD · Contact
  • Institute for Clinical and Experimental Medicine - IKEM
    Prague, Czechia
    Recruiting
    • Vojtech Melenovsky, MD · Contact
  • Heart and Lung Center, Helsinki University Hospital
    Helsinki, Finland
    Not yet recruiting
    • Jukka Lehtonen, MD · Contact
  • AOU Ospedali Riuniti Umberto I°-Lancisi-Salesi di Ancona
    Ancona, Italy
    Recruiting
    • Marco Marini, MD · Contact
    • Marco Marini, MD · Principal investigator
  • ASST Papa Giovanni XXIII
    Bergamo, Italy
    Recruiting
    • Aurelia Grosu, MD · Contact
    • Aurelia Grosu, MD · Principal investigator
  • Policlinico S.Orsola-Malpighi
    Bologna, Italy
    Recruiting
    • Luciano Potena, MD · Contact
    • Luciano Potena, MD · Principal investigator
  • ASST Spedali Civili
    Brescia, Italy
    Recruiting
    • Daniela Tomasoni, MD · Contact
    • Daniela Tomasoni, MD · Principal investigator
  • Azienda Ospedaliera "G.Brotzu"
    Cagliari, Italy
    Recruiting
    • Marco Corda, MD · Contact
    • Marco Corda, MD · Principal investigator
  • P.O. SS. Annunziata Chieti -ASL 2 Abruzzo
    Chieti, Italy
    Recruiting
    • Marco Zimarino, MD · Contact
  • Azienda Ospedaliero-Universitaria Careggi
    Florence, Italy
    Recruiting
    • Francesco Cappelli, MD · Contact
    • Francesco Cappelli, MD · Principal investigator
  • Ospedale Policlinico San Martino, IRCCS
    Genova, Italy
    Recruiting
    • Roberta Della Bona, MD · Contact
    • Roberta Della Bona, MD · Principal investigator
  • Azienda Socio-Sanitaria Territoriale (ASST) di Lecco
    Lecco, Italy
    Recruiting
    • Roberto Spoladore, MD · Contact
  • ASST Grande Ospedale Metropolitano Niguarda
    Milan, Italy
    Recruiting
  • Centro Cardiologico Monzino
    Milan, Italy
    Recruiting
    • Jeness Campodonico, MD · Contact
    • Jeness Campodonico, MD · Principal investigator
  • ASST Monza, Ospedale San Gerardo
    Monza, Italy
    Recruiting
    • Davide Corsi, MD · Contact
    • Davide Corsi · Principal investigator
  • Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi
    Naples, Italy
    Recruiting
    • Francesco Loffredo, MD · Contact
    • Francesco Loffredo, MD · Principal investigator
  • Azienda Ospedaliero Universitaria di Parma
    Parma, Italy
    Recruiting
    • Diego Ardissino, MD · Contact
    • Diego Ardissino, MD · Principal investigator
  • Fondazione IRCCS Policlinico San Matteo
    Pavia, Italy
    Recruiting
    • Rita Camporotondo, MD · Contact
    • Rita Camporotondo, MD · Principal investigator
  • Fondazione Toscana Gabriele Monasterio
    Pisa, Italy
    Recruiting
    • Michele Emdin, MD · Contact
    • Michele Emdin, MD · Principal investigator
  • Azienda Ospedaliera San Camillo Forlanini di Roma
    Roma, Italy
    Recruiting
    • Leonardo De Luca, MD · Contact
    • Leonardo De Luca, MD · Principal investigator
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Roma, Italy
    Recruiting
    • Maria Lucia Narducci, MD · Contact
    • Maria Lucia Narducci, MD · Principal investigator
  • Azienda Ospedaliera Universitaria Senese, Policlinico Santa Maria alle Scotte
    Siena, Italy
    Recruiting
    • Serafina Valente, MD · Contact
    • Serafina Valente, MD · Principal investigator
  • Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
    Torino, Italy
    Recruiting
    • Gaetano De Ferrari, MD · Contact
    • Gaetano De Ferrari, MD · Principal investigator
  • Presidio Ospedaliero Universitario "Santa Maria della Misericordia"
    Udine, Italy
    Recruiting
    • Massimo Imazio, MD · Contact
    • Massimo Imazio, MD · Principal investigator
  • University Medical Centre Ljubljana
    Ljubljana, Slovenia
    Recruiting
    • Andreja Černe, MD · Contact
  • Complexo Hospitalario Universitario A Coruña (CHUAC)
    A Coruña, Spain
    Recruiting
    • Maria G Crespo-Leiro, MD · Contact
  • Bellvitge University Hospital
    Barcelona, Spain
    Recruiting
    • Albert Ariza Sole, MD · Contact
  • Hospital de La Santa Creu I Sant Pau
    Barcelona, Spain
    Recruiting
    • Alessandro Sionis, MD · Contact
  • Hospital Universitario Vall d'Hebron
    Barcelona, Spain
    Recruiting
    • Aitor Uribarri, MD · Contact
  • Hospital 12 de Octubre
    Madrid, Spain
    Recruiting
    • Vanesa Bruña, MD · Contact
  • Hospital General Universitario Gregorio Marañón in Madrid
    Madrid, Spain
    Recruiting
    • Manuel Martínez Sellés, MD · Contact
  • Hospital Universitario Puerta de Hierro Majadahonda
    Madrid, Spain
    Recruiting
    • Fernando Domínguez, MD · Contact
  • Hospital Universitario Virgen de la Victoria
    Málaga, Spain
    Recruiting
    • Jose Manuel Garcia-Pinilla, MD · Contact
  • Hospital Universitario Virgen de la Arrixaca
    Murcia, Spain
    Recruiting
    • Domingo Pascual, MD · Contact
  • Sahlgrenska Universitetssjukhuset
    Göthenburg, Sweden
    Not yet recruiting
    • Entela Bollano, MD · Contact
  • Lund University and Skåne University Hospital
    Lund, Sweden
    Not yet recruiting
    • Oscar Braun, MD · Contact
  • Karolinska Universitetssjukhuset
    Stockholm, Sweden
    Not yet recruiting
    • Ida Haugen Löfman, MD · Contact
08

References and documents

Publications

  • Ammirati E, Frigerio M, Adler ED, Basso C, Birnie DH, Brambatti M, Friedrich MG, Klingel K, Lehtonen J, Moslehi JJ, Pedrotti P, Rimoldi OE, Schultheiss HP, Tschope C, Cooper LT Jr, Camici PG. Management of Acute Myocarditis and Chronic Inflammatory Cardiomyopathy: An Expert Consensus Document. Circ Heart Fail. 2020 Nov;13(11):e007405. doi: 10.1161/CIRCHEARTFAILURE.120.007405. Epub 2020 Nov 12. PubMed 33176455 ↗
  • Kociol RD, Cooper LT, Fang JC, Moslehi JJ, Pang PS, Sabe MA, Shah RV, Sims DB, Thiene G, Vardeny O; American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical Cardiology. Recognition and Initial Management of Fulminant Myocarditis: A Scientific Statement From the American Heart Association. Circulation. 2020 Feb 11;141(6):e69-e92. doi: 10.1161/CIR.0000000000000745. Epub 2020 Jan 6. PubMed 31902242 ↗
  • Ammirati E, Cipriani M, Moro C, Raineri C, Pini D, Sormani P, Mantovani R, Varrenti M, Pedrotti P, Conca C, Mafrici A, Grosu A, Briguglia D, Guglielmetto S, Perego GB, Colombo S, Caico SI, Giannattasio C, Maestroni A, Carubelli V, Metra M, Lombardi C, Campodonico J, Agostoni P, Peretto G, Scelsi L, Turco A, Di Tano G, Campana C, Belloni A, Morandi F, Mortara A, Ciro A, Senni M, Gavazzi A, Frigerio M, Oliva F, Camici PG; Registro Lombardo delle Miocarditi. Clinical Presentation and Outcome in a Contemporary Cohort of Patients With Acute Myocarditis: Multicenter Lombardy Registry. Circulation. 2018 Sep 11;138(11):1088-1099. doi: 10.1161/CIRCULATIONAHA.118.035319. PubMed 29764898 ↗
  • Ammirati E, Veronese G, Brambatti M, Merlo M, Cipriani M, Potena L, Sormani P, Aoki T, Sugimura K, Sawamura A, Okumura T, Pinney S, Hong K, Shah P, Braun O, Van de Heyning CM, Montero S, Petrella D, Huang F, Schmidt M, Raineri C, Lala A, Varrenti M, Foa A, Leone O, Gentile P, Artico J, Agostini V, Patel R, Garascia A, Van Craenenbroeck EM, Hirose K, Isotani A, Murohara T, Arita Y, Sionis A, Fabris E, Hashem S, Garcia-Hernando V, Oliva F, Greenberg B, Shimokawa H, Sinagra G, Adler ED, Frigerio M, Camici PG. Fulminant Versus Acute Nonfulminant Myocarditis in Patients With Left Ventricular Systolic Dysfunction. J Am Coll Cardiol. 2019 Jul 23;74(3):299-311. doi: 10.1016/j.jacc.2019.04.063. PubMed 31319912 ↗
  • Chen H, Liu J, Yang M. Corticosteroids for viral myocarditis. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD004471. doi: 10.1002/14651858.CD004471.pub2. PubMed 17054204 ↗
  • Mason JW, O'Connell JB, Herskowitz A, Rose NR, McManus BM, Billingham ME, Moon TE. A clinical trial of immunosuppressive therapy for myocarditis. The Myocarditis Treatment Trial Investigators. N Engl J Med. 1995 Aug 3;333(5):269-75. doi: 10.1056/NEJM199508033330501. PubMed 7596370 ↗
  • Ammirati E, Cipriani M, Lilliu M, Sormani P, Varrenti M, Raineri C, Petrella D, Garascia A, Pedrotti P, Roghi A, Bonacina E, Moreo A, Bottiroli M, Gagliardone MP, Mondino M, Ghio S, Totaro R, Turazza FM, Russo CF, Oliva F, Camici PG, Frigerio M. Survival and Left Ventricular Function Changes in Fulminant Versus Nonfulminant Acute Myocarditis. Circulation. 2017 Aug 8;136(6):529-545. doi: 10.1161/CIRCULATIONAHA.117.026386. Epub 2017 Jun 2. PubMed 28576783 ↗
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Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2021 (actual). Primary completion is estimated for Mar 2028, 77 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2021
First posted
Dec 9, 2021
StartActual
Oct 7, 2021
Primary completionEst.
Mar 2028
CompletionEst.
Dec 2028
Last update
Jul 31, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05150704
Lead sponsor
Niguarda Hospital
Collaborators
Ministry of Health, Italy, Istituto Di Ricerche Farmacologiche Mario Negri, University of Milano Bicocca, Regione Lombardia
Responsible party
Sponsor
First posted
Dec 9, 2021
Start date
Oct 7, 2021
Primary completion
Mar 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 31, 2025

Study contacts

Enrico Ammirati, MD, PhD
Contact
enrico.ammirati@ospedaleniguarda.it
+39 0264447791

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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