RecruitingPhase 3NCT05150704

MYTHS - MYocarditis THerapy With Steroids

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

Sponsor

Niguarda Hospital

Enrollment

288 participants

Start Date

Oct 7, 2021

Study Type

INTERVENTIONAL

Conditions

Myocarditis Acute

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

Min Age: 18 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study (called MYTHS) is testing whether giving corticosteroids (steroid medications) to patients hospitalized with suspected acute myocarditis (inflammation of the heart muscle) can improve heart recovery. Patients who are admitted with heart failure and suspected myocarditis will be randomly assigned to receive either steroids or a placebo. **You may be eligible if...** - You are between 18 and 69 years old and admitted to the hospital with suspected acute myocarditis - You have signs of heart failure with elevated heart failure markers in your blood - Your heart's pumping function is significantly reduced (ejection fraction below 41%) - Your troponin (a marker of heart damage) is elevated - Symptoms started within the past 3 weeks - You are being randomized within 120 hours (5 days) of hospital admission **You may NOT be eligible if...** - You have a known autoimmune disease or are already on steroids or immunosuppressive therapy - You have an active bacterial or fungal infection - You have known HIV or tuberculosis - You suffered a cardiac arrest outside the hospital - You are pregnant - You have another serious condition with life expectancy under 12 months - Your myocarditis is linked to cancer immunotherapy drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(49)

University of California San Diego

San Diego, California, United States

University of Texas

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Medical University of Graz

Graz, Austria

Medical University Innsbruck

Innsbruck, Austria

Medical University of Wien

Vienna, Austria

Onze Lieve Vrouwziekenhuis

Aalst, Belgium

Antwerp University Hospital

Edegem, Belgium

Jessa Hospital Hasselt

Hasselt, Belgium

University Hospitals Leuven

Leuven, Belgium

Masaryk University and St. Anne's University Hospital

Brno, Czechia

Charles University in Prague and General University Hospital

Prague, Czechia

Institute for Clinical and Experimental Medicine - IKEM

Prague, Czechia

Heart and Lung Center, Helsinki University Hospital

Helsinki, Finland

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

Ancona, Italy

ASST Papa Giovanni XXIII

Bergamo, Italy

Policlinico S.Orsola-Malpighi

Bologna, Italy

ASST Spedali Civili

Brescia, Italy

Azienda Ospedaliera "G.Brotzu"

Cagliari, Italy

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

Chieti, Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Ospedale Policlinico San Martino, IRCCS

Genova, Italy

Azienda Socio-Sanitaria Territoriale (ASST) di Lecco

Lecco, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Centro Cardiologico Monzino

Milan, Italy

ASST Monza, Ospedale San Gerardo

Monza, Italy

Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi

Naples, Italy

Azienda Ospedaliero Universitaria di Parma

Parma, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Fondazione Toscana Gabriele Monasterio

Pisa, Italy

Azienda Ospedaliera San Camillo Forlanini di Roma

Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Azienda Ospedaliera Universitaria Senese, Policlinico Santa Maria alle Scotte

Siena, Italy

Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

Torino, Italy

Presidio Ospedaliero Universitario "Santa Maria della Misericordia"

Udine, Italy

University Medical Centre Ljubljana

Ljubljana, Slovenia

Complexo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, Spain

Bellvitge University Hospital

Barcelona, Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital 12 de Octubre

Madrid, Spain

Hospital General Universitario Gregorio Marañón in Madrid

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Sahlgrenska Universitetssjukhuset

Göthenburg, Sweden

Lund University and Skåne University Hospital

Lund, Sweden

Karolinska Universitetssjukhuset

Stockholm, Sweden

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NCT05150704

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