Actively Recruiting

Phase 3
Age: 18Years - 69Years
All Genders
ID05150704

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

Led by Niguarda Hospital · Updated on 2025-07-31

288

Participants Needed

49

Research Sites

39 weeks

Total Duration

On this page

Sponsors

N

Niguarda Hospital

Lead Sponsor

M

Ministry of Health, Italy

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of pulsed intravenous methylprednisolone compared to standard therapy in patients with acute myocarditis, a condition marked by inflammation and damage to heart muscle cells not caused by reduced blood flow. This phase III, international, single-blind randomized controlled trial focuses on patients with complicated or fulminant acute myocarditis who experience reduced heart function and may require intensive supportive care. The study aims to determine if early corticosteroid therapy can improve outcomes by reducing inflammation in the heart during the acute phase, which has not been tested previously despite the high risks of this condition. Participants will be randomly assigned to receive either pulsed corticosteroid therapy with methylprednisolone (1 gram intravenously once daily for three days) alongside standard maximal supportive care or a placebo (saline solution intravenously once daily for three days) plus standard care. The study includes a single-blind design and plans to recruit 360 patients, with treatments initiated within 120 hours of hospital admission. Follow-up and analysis will focus on comparing the impact of these treatments on survival and heart function over six months. During the trial, participants will undergo assessments including echocardiograms, cardiac magnetic resonance imaging, blood tests for heart injury markers, and monitoring of heart rhythms. Researchers will track major events such as death, need for heart transplant or mechanical support, arrhythmias, and hospital readmissions related to heart failure or abnormal heart rhythms. The study will also monitor safety outcomes and collect data for up to six months after treatment to evaluate the treatments' effects and gather long-term information on heart recovery and patient health.

CONDITIONS

Brief Title

MYTHS - MYocarditis THerapy With Steroids

Who Can Participate

Age: 18Years - 69Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients admitted to hospital for suspected acute myocarditis
  • Age between 18 and 69 years
  • Acute heart failure with clinically suspected acute myocarditis based on NT-proBNP ≥1600 pg/mL or BNP ≥400 pg/mL
  • Left ventricular ejection fraction below 41% and left ventricular end diastolic diameter less than 56 mm on echocardiogram
  • Increased troponin levels at least 3 times above the upper reference limit at randomization
  • Cardiac symptoms started within 3 weeks before randomization
  • Coronary artery disease excluded by angiogram in patients 46 years or older if myocarditis is not proven by histology
  • Randomization occurs within 120 hours from hospital admission
Not Eligible

You will not qualify if you...

  • Known systemic autoimmune disorder or other conditions where immunosuppression is usually used
  • Current chronic corticosteroid or immunosuppressive therapy (excluding colchicine or NSAIDs)
  • Allergy or contraindication to corticosteroids
  • Persistent peripheral eosinophilia above 7% or known hypereosinophilic syndrome
  • Myocarditis related to immune checkpoint inhibitor treatment
  • Chronic cardiac disease excluding previous myocarditis with functional recovery
  • Active bacterial or fungal infection or suspected infection with high procalcitonin
  • Known chronic infections like HIV or tuberculosis
  • Out-of-hospital cardiac arrest
  • Mechanical circulatory support started more than 48 hours before randomization
  • Judged too sick to start mechanical support
  • Echocardiogram suggests other cardiac diseases such as endocarditis
  • Participation in another clinical trial
  • Pregnant women or positive pregnancy test for women aged 18-50
  • Any other serious disease expected to limit life expectancy to less than 12 months or interfere with participation or results of the trial

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 days

Participants receive pulsed intravenous corticosteroid therapy or placebo on top of standard therapy and maximal supportive care to treat acute myocarditis.

Daily visits for 3 days (in-person)

Follow-up

Duration - Up to 6 months

Participants are monitored for up to 6 months after treatment to assess safety and efficacy outcomes including cardiac function and adverse events.

Multiple follow-up visits over 6 months

Trial Site Locations

Total: 49 locations

1

University of California San Diego

San Diego, California, United States, 92093

Actively Recruiting

2

University of Texas

Houston, Texas, United States, 77204

Not Yet Recruiting

3

University of Virginia

Charlottesville, Virginia, United States, 22903

Actively Recruiting

4

Virginia Commonwealth University

Richmond, Virginia, United States, 23284

Not Yet Recruiting

5

Medical University of Graz

Graz, Austria

Actively Recruiting

6

Medical University Innsbruck

Innsbruck, Austria

Not Yet Recruiting

7

Medical University of Wien

Vienna, Austria

Actively Recruiting

8

Onze Lieve Vrouwziekenhuis

Aalst, Belgium

Actively Recruiting

9

Antwerp University Hospital

Edegem, Belgium

Actively Recruiting

10

Jessa Hospital Hasselt

Hasselt, Belgium

Actively Recruiting

11

University Hospitals Leuven

Leuven, Belgium

Actively Recruiting

12

Masaryk University and St. Anne's University Hospital

Brno, Czechia

Actively Recruiting

13

Charles University in Prague and General University Hospital

Prague, Czechia

Actively Recruiting

14

Institute for Clinical and Experimental Medicine - IKEM

Prague, Czechia

Actively Recruiting

15

Heart and Lung Center, Helsinki University Hospital

Helsinki, Finland

Not Yet Recruiting

16

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

Ancona, Italy

Actively Recruiting

17

ASST Papa Giovanni XXIII

Bergamo, Italy

Actively Recruiting

18

Policlinico S.Orsola-Malpighi

Bologna, Italy

Actively Recruiting

19

ASST Spedali Civili

Brescia, Italy

Actively Recruiting

20

Azienda Ospedaliera "G.Brotzu"

Cagliari, Italy

Actively Recruiting

21

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

Chieti, Italy

Actively Recruiting

22

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Actively Recruiting

23

Ospedale Policlinico San Martino, IRCCS

Genova, Italy

Actively Recruiting

24

Azienda Socio-Sanitaria Territoriale (ASST) di Lecco

Lecco, Italy

Actively Recruiting

25

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Actively Recruiting

26

Centro Cardiologico Monzino

Milan, Italy

Actively Recruiting

27

ASST Monza, Ospedale San Gerardo

Monza, Italy

Actively Recruiting

28

Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi

Naples, Italy

Actively Recruiting

29

Azienda Ospedaliero Universitaria di Parma

Parma, Italy

Actively Recruiting

30

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Actively Recruiting

31

Fondazione Toscana Gabriele Monasterio

Pisa, Italy

Actively Recruiting

32

Azienda Ospedaliera San Camillo Forlanini di Roma

Roma, Italy

Actively Recruiting

33

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Actively Recruiting

34

Azienda Ospedaliera Universitaria Senese, Policlinico Santa Maria alle Scotte

Siena, Italy

Actively Recruiting

35

Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

Torino, Italy

Actively Recruiting

36

Presidio Ospedaliero Universitario "Santa Maria della Misericordia"

Udine, Italy

Actively Recruiting

37

University Medical Centre Ljubljana

Ljubljana, Slovenia

Actively Recruiting

38

Complexo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, Spain

Actively Recruiting

39

Bellvitge University Hospital

Barcelona, Spain

Actively Recruiting

40

Hospital de La Santa Creu I Sant Pau

Barcelona, Spain

Actively Recruiting

41

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Actively Recruiting

42

Hospital 12 de Octubre

Madrid, Spain

Actively Recruiting

43

Hospital General Universitario Gregorio Marañón in Madrid

Madrid, Spain

Actively Recruiting

44

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Spain

Actively Recruiting

45

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Actively Recruiting

46

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Actively Recruiting

47

Sahlgrenska Universitetssjukhuset

Göthenburg, Sweden

Not Yet Recruiting

48

Lund University and Skåne University Hospital

Lund, Sweden

Not Yet Recruiting

49

Karolinska Universitetssjukhuset

Stockholm, Sweden

Not Yet Recruiting

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Research Team

E

Enrico Ammirati, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Recognition and Initial Management of Fulminant Myocarditis: A Scientific Statement From the American Heart Association.

Robb D Kociol, Leslie T Cooper, James C Fang...

https://pubmed.ncbi.nlm.nih.gov/31902242

Clinical Presentation and Outcome in a Contemporary Cohort of Patients With Acute Myocarditis: Multicenter Lombardy Registry.

Enrico Ammirati, Manlio Cipriani, Claudio Moro...

https://pubmed.ncbi.nlm.nih.gov/29764898

Fulminant Versus Acute Nonfulminant Myocarditis in Patients With Left Ventricular Systolic Dysfunction.

Enrico Ammirati, Giacomo Veronese, Michela Brambatti...

https://pubmed.ncbi.nlm.nih.gov/31319912

Fulminant Lymphocytic Myocarditis During Pregnancy Treated With Temporary Mechanical Circulatory Supports and Aggressive Immunosuppression.

Giacomo Veronese, Sandra Nonini, Aldo Cannata...

https://pubmed.ncbi.nlm.nih.gov/36305298