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Myocarditis Therapy with Steroids in patients with a Mildly Reduced ejection fraction (MYTHS-MR)
EU CTIS ID: 2022-501547-33-01
What this study is testing
The primary objective is to demonstrate an increase in the rate of the primary composite endpoint (LVEF ≥55% or an absolute increase in LVEF≥10% on echocardiogram after 5 days from randomization) in patients treated with pulsed corticosteroid therapy vs. standard therapy.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18 years or older and below 70 years (18-69 years)
- LVEF<50% and LV-EDD<56 mm (parasternal long-axis view) on echocardiogram
- Increased troponin (3x URL) at the time of randomization
- Clinically suspected myocarditis with 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
You likely can't join if
- 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 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
- Myocarditis associated with the ongoing administration of anti-cancer immune checkpoint inhibitor (ICI) agents
- Previously known chronic cardiac disease
- 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 before randomisation
See the full eligibility criteria
Who can join
- Age 18 years or older and below 70 years (18-69 years)
- LVEF<50% and LV-EDD<56 mm (parasternal long-axis view) on echocardiogram
- Increased troponin (3x URL) at the time of randomization
- Clinically suspected myocarditis with 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
- Endomyocardial biopsy (EMB) is not considered necessary before randomization and performing EMB is based on the decision of the local team
- Patient has voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC) or institutional review board (IRB), after the nature of the study has been explained and the patient has had the opportunity to ask questions.
What rules you out
- 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 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
- Myocarditis associated with the ongoing administration of anti-cancer immune checkpoint inhibitor (ICI) agents
- Previously known chronic cardiac disease
- 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 before randomisation
- Contraindication for CMRI
- 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
- If LVEF<41%, 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; (if LVEF 41%-<50% any NT-proBNP or BNP concentration is allowed).
- Patients already on oral/IV chronic corticosteroid therapy or other chronic immunosuppressive therapies
- Contraindication to corticosteroids, including history of previous (steroid) psychosis, 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.