AzTrials
AzTrials

Myocarditis AcutePhase 3MYTHSNCT05150704

MYTHS - MYocarditis THerapy With Steroids

A Phase 3 study testing Methylprednisolone and saline solution in people with Myocarditis Acute, run by Niguarda Hospital at 49 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Myocarditis Acute
What is being tested?
Methylprednisolone and saline solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
288 participants
Where
49 sitesin 9 countries
Study dates
7 Oct 2021to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 15Show fewer
  • 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.

Trial locations and contacts

49 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Enrico Ammirati, MD, PhD contact

+39 0264447791

enrico.ammirati@ospedaleniguarda.it

49 sites in 9 countries

Italy21 sites, 21 recruiting

  • AOU Ospedali Riuniti Umberto I°-Lancisi-Salesi di Ancona

    Ancona

    Marco Marini, MD

    Marco Marini, MD

    Recruiting

  • ASST Papa Giovanni XXIII

    Bergamo

    Aurelia Grosu, MD

    Aurelia Grosu, MD

    Recruiting

  • Policlinico S.Orsola-Malpighi

    Bologna

    Luciano Potena, MD

    Luciano Potena, MD

    Recruiting

  • ASST Spedali Civili

    Brescia

    Daniela Tomasoni, MD

    Daniela Tomasoni, MD

    Recruiting

  • Azienda Ospedaliera "G.Brotzu"

    Cagliari

    Marco Corda, MD

    Marco Corda, MD

    Recruiting

  • P.O. SS. Annunziata Chieti -ASL 2 Abruzzo

    Chieti

    Marco Zimarino, MD

    Recruiting

  • Azienda Ospedaliero-Universitaria Careggi

    Florence

    Francesco Cappelli, MD

    Francesco Cappelli, MD

    Recruiting

  • Ospedale Policlinico San Martino, IRCCS

    Genova

    Roberta Della Bona, MD

    Roberta Della Bona, MD

    Recruiting

  • Azienda Socio-Sanitaria Territoriale (ASST) di Lecco

    Lecco

    Roberto Spoladore, MD

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan

    Enrico Ammirati, MD, 02 6444 7791, enrico.ammirati@ospedaleniguarda.it

    Enrico Ammirati, MD

    Recruiting

  • Centro Cardiologico Monzino

    Milan

    Jeness Campodonico, MD

    Jeness Campodonico, MD

    Recruiting

  • ASST Monza, Ospedale San Gerardo

    Monza

    Davide Corsi, MD

    Davide Corsi

    Recruiting

  • Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi

    Naples

    Francesco Loffredo, MD

    Francesco Loffredo, MD

    Recruiting

  • Azienda Ospedaliero Universitaria di Parma

    Parma

    Diego Ardissino, MD

    Diego Ardissino, MD

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia

    Rita Camporotondo, MD

    Rita Camporotondo, MD

    Recruiting

  • Fondazione Toscana Gabriele Monasterio

    Pisa

    Michele Emdin, MD

    Michele Emdin, MD

    Recruiting

  • Azienda Ospedaliera San Camillo Forlanini di Roma

    Roma

    Leonardo De Luca, MD

    Leonardo De Luca, MD

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma

    Maria Lucia Narducci, MD

    Maria Lucia Narducci, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Senese, Policlinico Santa Maria alle Scotte

    Siena

    Serafina Valente, MD

    Serafina Valente, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

    Torino

    Gaetano De Ferrari, MD

    Gaetano De Ferrari, MD

    Recruiting

  • Presidio Ospedaliero Universitario "Santa Maria della Misericordia"

    Udine

    Massimo Imazio, MD

    Massimo Imazio, MD

    Recruiting

Other trials in Italy

Spain9 sites, 9 recruiting

  • Complexo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña

    Maria G Crespo-Leiro, MD

    Recruiting

  • Bellvitge University Hospital

    Barcelona

    Albert Ariza Sole, MD

    Recruiting

  • Hospital de La Santa Creu I Sant Pau

    Barcelona

    Alessandro Sionis, MD

    Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona

    Aitor Uribarri, MD

    Recruiting

  • Hospital 12 de Octubre

    Madrid

    Vanesa Bruña, MD

    Recruiting

  • Hospital General Universitario Gregorio Marañón in Madrid

    Madrid

    Manuel Martínez Sellés, MD

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid

    Fernando Domínguez, MD

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga

    Jose Manuel Garcia-Pinilla, MD

    Recruiting

  • Hospital Universitario Virgen de la Arrixaca

    Murcia

    Domingo Pascual, MD

    Recruiting

Other trials in Spain

United States4 sites, 4 recruiting

  • University of Virginia

    Charlottesville, Virginia, 22903

    Antonio Abbate, MD

    Recruiting

  • University of Texas

    Houston, Texas, 77204

    Angelo Nascimbene, MD

    Not yet recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23284

    Roshanak Markley, MD

    Not yet recruiting

  • University of California San Diego

    San Diego, California, 92093

    Eric D Adler, MD

    Recruiting

Other trials in United States

Belgium4 sites, 4 recruiting

  • Onze Lieve Vrouwziekenhuis

    Aalst

    Mark Heggermont, MD

    Recruiting

  • Antwerp University Hospital

    Edegem

    Caroline Van De Heyning, MD

    Recruiting

  • Jessa Hospital Hasselt

    Hasselt

    Philippe Jr Timmermans, MD

    Recruiting

  • University Hospitals Leuven

    Leuven

    Walter Droogné, MD

    Recruiting

Other trials in Belgium

Austria3 sites, 3 recruiting

  • Medical University of Graz

    Graz

    Markus Wallner, MD

    Recruiting

  • Medical University Innsbruck

    Innsbruck

    Gerhard Poelzl, MD

    Not yet recruiting

  • Medical University of Wien

    Vienna

    Max Lenz, MD

    Recruiting

Other trials in Austria

Czechia3 sites, 3 recruiting

  • Masaryk University and St. Anne's University Hospital

    Brno

    Jan Krejčí, MD

    Recruiting

  • Charles University in Prague and General University Hospital

    Prague

    Petr Kuchynka, MD

    Recruiting

  • Institute for Clinical and Experimental Medicine - IKEM

    Prague

    Vojtech Melenovsky, MD

    Recruiting

Other trials in Czechia

Sweden3 sites, 3 recruiting

  • Sahlgrenska Universitetssjukhuset

    Göthenburg

    Entela Bollano, MD

    Not yet recruiting

  • Lund University and Skåne University Hospital

    Lund

    Oscar Braun, MD

    Not yet recruiting

  • Karolinska Universitetssjukhuset

    Stockholm

    Ida Haugen Löfman, MD

    Not yet recruiting

Other trials in Sweden

Finland1 site, 1 recruiting

  • Heart and Lung Center, Helsinki University Hospital

    Helsinki

    Jukka Lehtonen, MD

    Not yet recruiting

Other trials in Finland

Slovenia1 site, 1 recruiting

  • University Medical Centre Ljubljana

    Ljubljana

    Andreja Černe, MD

    Recruiting

Other trials in Slovenia

About this study

Official title: Single Blind Randomized Controlled Trial to Assess the Safety and Efficacy of High Dose Pulse Intravenous Corticosteroid Therapy to Treat Patients With Complicated/Fulminant Acute Myocarditis

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\&#39;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

Being tested
Methylprednisolone, saline solution
Keywords
Acute Myocarditis, Corticosteroid therapy, Myocarditis, Trial, Immunosuppression, Acute heart failure, Fulminant acute myocarditis
Medical subject headings
Myocarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethylprednisoloneDrug

    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 solutionDrug

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

Study groups in NCT05150704
Study groupRoleWhat they receive
Experimental armExperimentalPulsed 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
Receives: Drug: Methylprednisolone
Control armPlacebo comparatorPlacebo (saline solution 250 mL IV qd for 3 days) on top of standard therapy and maximal supportive care.
Receives: Drug: saline solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months from patients enrollment

Secondary outcomes (11)

  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.

    Measured: 6 months from patients enrollment

  2. Mortality

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

    Measured: 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).

    Measured: 6 months from patients enrollment

  4. Number of days on t-MCS from randomization

    Number of days on t-MCS from randomization

    Measured: 6 months from patients enrollment

  5. Number of days in ICU from randomization

    Number of days in ICU from randomization

    Measured: 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

    Measured: 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).

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 6 months from patients enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2021
  2. Study start7 Oct 2021
  3. Primary completionMar 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single blind randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
288 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05150704
Sponsor's protocol ID
MYTHS
Acronym
MYTHS
Status last verified
Jul 2025
First submitted
14 Nov 2021
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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

  • Ammirati E, Moslehi JJ. Diagnosis and Treatment of Acute Myocarditis: A Review. JAMA. 2023 Apr 4;329(13):1098-1113. doi: 10.1001/jama.2023.3371.

    PubMed 37014337

  • Veronese G, Nonini S, Cannata A, Aresta F, Olivieri G, Montrasio E, De Caria D, Perna E, Calini A, Bottiroli M, Cislaghi F, Pedrazzini G, Baltaro F, Quattrocchi G, Pedrotti P, Russo CF, Garascia A, Mondino M, Ammirati E. Fulminant Lymphocytic Myocarditis During Pregnancy Treated With Temporary Mechanical Circulatory Supports and Aggressive Immunosuppression. Circ Heart Fail. 2022 Dec;15(12):e009810. doi: 10.1161/CIRCHEARTFAILURE.122.009810. Epub 2022 Oct 28. No abstract available.

    PubMed 36305298

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methylprednisolone and saline solution in people with Myocarditis Acute, run by Niguarda Hospital at 49 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Italy, Spain, United States, Belgium, Austria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Enrico Ammirati, MD, PhD (+39 0264447791, enrico.ammirati@ospedaleniguarda.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 6 months from patients enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05150704, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in