Steroid infusions for adults with severe sudden heart muscle inflammation
Tests methylprednisolone given into a vein in adults with severe acute myocarditis.
Plain-language title generated from the registry record
Registry title: MYTHS - MYocarditis THerapy With Steroids
Key facts
- Where
- Brno and Prague, CzechiaSee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 69 in hospital with suspected sudden heart muscle inflammation (acute myocarditis) and heart failure. It tests high-dose steroids into a vein against standard care.
- Age
- 18 to 69 years
- Sex
- All sexes
- Disease stage
- Suspected acute myocarditis with acute heart failure. Heart symptoms began within 3 weeks of randomization. Heart pumping (LVEF) below 41% and left ventricle end-diastolic diameter below 56 mm on heart ultrasound. Troponin at least 3 times the upper reference limit. NT-proBNP of 1600 pg/mL or more, or BNP of 400 pg/mL or more. Randomization within 120 hours of hospital admission.
- Earlier treatment
- People already on long-term steroids by mouth or vein, or other long-term immune-suppressing treatment, cannot join. Colchicine and NSAIDs do not count as immune-suppressing drugs. Temporary mechanical circulatory support (t-MCS) started more than 48 hours before randomization is not allowed.
- Biomarker or test result
- NT-proBNP of 1600 pg/mL or more, or BNP of 400 pg/mL or more. Troponin at least 3 times the upper reference limit. For people aged 46 or older without a biopsy-proven diagnosis, a coronary angiogram must have ruled out coronary artery disease.
Main reasons for not taking part
- Known autoimmune disease or other condition where immune suppression is expected to help
- Allergy or other reason not to take corticosteroids
- Active bacterial or fungal infection, or known HIV or tuberculosis
- Myocarditis linked to current cancer immune checkpoint inhibitor drugs
- Pregnancy, known or with a positive pregnancy test (women aged 18 to 50)
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 69 years old?
Source: NCT05150704, who can take part
Where in Czechia
- Masaryk University and St. Anne's University HospitalBrno, CzechiaContact: Jan Krejčí, MDTaking people
- Charles University in Prague and General University HospitalPrague, CzechiaContact: Petr Kuchynka, MDTaking people
- Institute for Clinical and Experimental Medicine (IKEM)Prague, CzechiaContact: Vojtech Melenovsky, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Niguarda Hospital
- Trial code
- NCT05150704
- Record updated
- 31 July 2025
- Original description
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 full original descriptionShow less
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).
Inclusion: 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: 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); 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); 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; Contraindication to corticosteroids, including allergies to this medication and its excipients; Myocarditis associated with the ongoing administration of anti-cancer immune checkpoint inhibitor (ICI) agents; Known chronic infective disease, such as HIV infection or tuberculosis; out-of-hospital cardiac arrest; 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); 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; 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; 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; Pregnant women (known pregnancy) or POSITIVE human chorionic gonadotropin (HCG) test measures (urine/blood) for women of 18-50 years of age; t-MCS instituted more than 48 hours before randomization; Participants involved in another clinical trial.