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

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ClinicalTrials.gov Identifier: NCT05974462
Recruitment Status : Not yet recruiting
First Posted : August 3, 2023
Last Update Posted : November 29, 2023
Sponsor:
Collaborator:
Niguarda Hospital
Information provided by (Responsible Party):
University Hospital, Antwerp

Study Description
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Brief 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 control group will be treated with a saline solution on top of their standard therapy. All other tests are executed according to standard of care.


Condition or disease Intervention/treatment Phase
Myocarditis Acute Drug: Methylprednisolone 125 MG [Solu-Medrol] Other: IV saline solution 250 mL [Placebo] Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single Blind, Investigator-initiated, Randomized Controlled Trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Single-blind, Investigator-initiated, Randomized, Controlled Trial to Assess the Safety and Efficacy of Intravenous Corticosteroid Therapy to Treat Patients With Acute Myocarditis With Mildly Reduced Left Ventricular Ejection Fraction
Estimated Study Start Date : January 1, 2024
Estimated Primary Completion Date : October 1, 2026
Estimated Study Completion Date : October 1, 2028

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Standard therapy
IV saline solution 250 mL daily for 3 days on top of standard therapy.
 Other: IV saline solution 250 mL [Placebo]
Saline solution 250 mL
Experimental: Pulsed corticosteroid therapy
IV methylprednisolone 125 mg daily for 3 days diluted in saline solution 250 ml on top of standard therapy.
 Drug: Methylprednisolone 125 MG [Solu-Medrol]
125 mg daily for 3 days diluted in saline solution 250 mL


Outcome Measures
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Primary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: 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).


Secondary Outcome Measures :
  1. Improvement of the composite endpoint [ Time Frame: 6 months ]
    Proportion of patients with LVEF<55% AND/OR LV dilation on 6-month cardiac magnetic resonance imaging (CMRI) (CMRI clips will be centrally reviewed in a blind fashion by readers)

  2. Composite endpoint defined as the time from randomization to the first event [ Time Frame: Within 6 months and 2 years ]
    among: (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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05974462


Contacts
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Contact: Caroline Van De Heyning, MD PhD +32 821 3538 caroline.vandeheyning@uza.be
Contact: Nicole Sturkenboom, MD +32 821 3538 helene.sturkenboom@uza.be

Locations
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Italy
Niguarda Hospital
Milan, Italy, 20125
Contact: Enrico Ammirati, MD PhD    +39 264447791    enrico.ammirati@ospedaleniguarda.it   
Sponsors and Collaborators
University Hospital, Antwerp
Niguarda Hospital
More Information
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Publications:

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Responsible Party: University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT05974462    
Other Study ID Numbers: 2022-501547-33-00
First Posted: August 3, 2023    Key Record Dates
Last Update Posted: November 29, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents