Ireland
--:--IST
Recruiting Phase 3

MYTHS-MR Trial (MYocarditis THerapy With Steroids in Patients With Mildly Reduced Ejection Fraction)

NCT05974462 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2024-05-24
Last updated
2025-04-17

Condition(s) studied

Acute Myocarditis

Investigational drug(s) / intervention(s)

Methylprednisolone 125 MG →IV saline solution 0.9%

Methylprednisolone 125 MG: 125 mg daily for 3 days diluted in saline solution 250 mL

IV saline solution 0.9%: Saline solution 0.9% 250 mL

Study summary

The goal of this clinical trial is to demonstrate the efficacy of pulsed intravenous methylprednisolone in a single-blind randomized controlled trial versus standard therapy in patients with acute myocarditis and a mildly reduced LVEF.

The main question\[s\] it aims to answer are:

* is there an increase in 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?
* is there a reduction in the proportion of patients with LVEF \< 55% AND/OR LV dilation on a 6-month CMRI in patients treated pulsed corticosteroid therapy vs. standard therapy?
* To assess the effect of corticosteroids on the occurrence of the combined endpoint(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.

Participants will be randomized in two arms in a 1:1 ratio. The experimental group will receive pulsed corticosteroid therapy on top of the standard therapy and patients in the placebo group will be treated with a saline solution on top of their standard therapy. All other tests are executed according to standard of care.

Eligibility

Sex
ALL
Min age
18 Years
Max age
69 Years
Healthy volunteers
No
Inclusion Criteria: * LVEF\<50% and LV-EDD\<56 mm (parasternal long-axis view) on echocardiogram; * Increased troponin (3x 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. * Endomyocardial biopsy (EMB) is not considered necessary before randomization and performing EMB is based on the decision of the local team. Exclusion Criteria: * 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; * 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 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 (i.e., previous cardiomyopathy, that does NOT include previous myocarditis if there is a functional recovery at the time of screening); * 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; * 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).

Primary outcome measure(s)

  • Left ventricular ejection fraction — Day 5
    LVEF ≥55% or an absolute increase in LVEF≥10% on echocardiogram after 5 days from randomization (echocardiographic clips will be centrally reviewed in a blind fashion by readers).

Trial sites (19)

FacilityCityRegionStatus
Antwerp University Hospital Edegem Antwerp Recruiting
Onze-Lieve-Vrouwziekenhuis (OLV ziekenhuis) Aalst Belgium Recruiting
Middelheim Ziekenhuis Antwerp Belgium Recruiting
Jessa ziekenhuis Hasselt Belgium Recruiting
Universitair ziekenhuis Leuven Leuven Belgium Recruiting
Niguarda Hospital Milan Milan Recruiting
Azienda USL Toscane SUD Est Arezzo Italy Not Yet Recruiting
Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy Not Yet Recruiting
ASST Spedali Civili di Brescia Brescia Italy Not Yet Recruiting
Careggi University Hospital Florence Italy Not Yet Recruiting
Alessandro Manzoni hospital Lecco Italy Not Yet Recruiting
San Raffaele Hospital Milan Italy Not Yet Recruiting
Ospedale Maggiore di Milano Milan Italy Not Yet Recruiting
Fondazione IRCCS Policlinico San Matteo Pavia Italy Not Yet Recruiting
Fondazione Toscana Gabriele Monasterio Pisa Italy Not Yet Recruiting
Policlinico Universitario Agostino Gemelli Roma Italy Not Yet Recruiting
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy Not Yet Recruiting
University Medical Centre of Ljubljana Ljubljana Slovenia Recruiting
Hospital Universitario A Coruña (CHUAC) A Coruña Spain Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05974462 on ClinicalTrials.gov ↗ ← All trials in Spain