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Study on the Safety and Effectiveness of Methylprednisolone Sodium Succinate and Sodium Chloride for Patients with Severe Cardiac Inflammation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of acute myocarditis, a condition characterized by severe inflammation of the heart. The treatment being tested is a high-dose pulse of intravenous corticosteroid therapy, specifically using a medication called methylprednisolone sodium succinate, known by the brand name Solu Medrol. This medication is administered as a solution for injection. The study also involves the use of a solution for infusion containing sodium chloride, which is commonly used in medical treatments.

The purpose of the study is to assess the safety and effectiveness of this corticosteroid therapy in patients with complicated or fulminant acute myocarditis. Participants in the study will receive either the corticosteroid treatment or standard therapy with maximal supportive care. The study will monitor the participants over a period of six months to observe any significant events such as death, heart transplant, or the need for advanced heart support devices.

Throughout the study, various health indicators will be tracked, including heart function and levels of certain proteins in the blood that indicate heart stress. The study aims to determine if the corticosteroid treatment can reduce the occurrence of serious heart-related events compared to standard care. Participants will be closely monitored during their hospital stay and after discharge to ensure their safety and to gather comprehensive data on the treatment's impact.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, randomization occurs within 120 hours of hospital admission. This process assigns you to either the treatment group receiving high-dose pulse intravenous corticosteroid therapy or the standard therapy group.

  2. Step 2

    Treatment administration

    If assigned to the treatment group, you will receive a medication called methylprednisolone sodium succinate through an intravenous infusion. This is a high-dose corticosteroid therapy aimed at reducing severe cardiac inflammation.

    The infusion is administered in a hospital setting to ensure safety and monitor your response to the treatment.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, your health will be closely monitored. This includes regular assessments of heart function using echocardiograms and other tests to measure heart-related biomarkers.

    Your progress will be evaluated at various intervals, including after 3 days, 5 days, and 6 months from the start of the trial.

  4. Step 4

    Primary and secondary outcomes

    The primary outcome of the trial is to observe the time from randomization to the first occurrence of specific events such as all-cause death, heart transplant, or rehospitalization due to heart failure or arrhythmias within 6 months.

    Secondary outcomes include measuring changes in heart function, such as left ventricular ejection fraction, and monitoring any reduction in heart rate or troponin levels, which are indicators of heart stress.

  5. Step 5

    End of trial

    The trial is expected to conclude by December 31, 2028. Your participation will contribute to understanding the effectiveness and safety of the treatment for severe cardiac inflammation.

Who can join the trial?

7 criteria

  • Must be between 18 and 69 years old.
  • Have a condition called acute heart failure with suspected acute myocarditis. This is based on specific blood tests: an N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of 1600 pg/mL or more, or a B-type natriuretic peptide (BNP) level of 400 pg/mL or more. These tests help measure heart stress.
  • Have a left ventricular ejection fraction (LVEF) of less than 41%. This is a measure of how well the heart pumps blood. Also, the left ventricular end diastolic diameter (LV-EDD) should be less than 56 mm, as seen on an echocardiogram, which is an ultrasound of the heart.
  • Have increased levels of a protein called troponin, which is three times higher than the normal limit. This indicates heart muscle damage.
  • Experienced the start of heart-related symptoms within 3 weeks before joining the study.
  • For those aged 46 or older, must have had a test called a coronary angiogram to rule out coronary artery disease, unless myocarditis is confirmed by a tissue test.
  • Must be able to join the study within 120 hours (5 days) of being admitted to the hospital.

Who cannot join the trial?

1 criterion

  • Patients with severe cardiac inflammation cannot participate. This means if you have a serious condition where your heart is inflamed, you are not eligible.
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Investigated drugs

Corticosteroid Therapy is used in this trial to treat patients with complicated or severe acute myocarditis. This therapy involves administering high doses of corticosteroids intravenously in pulses. The goal is to reduce inflammation in the heart muscle and improve the patient's condition by decreasing the rate of adverse outcomes associated with myocarditis.

What is already known about the treatment

Corticosteroid Therapy – This medication is administered intravenously in high doses as a pulse therapy. It is currently being studied in clinical trials to evaluate its safety and effectiveness in treating severe cardiac inflammation, specifically acute myocarditis. The main therapeutic indication is to reduce inflammation in the heart, potentially improving patient outcomes. At the molecular level, corticosteroids work by suppressing the immune system and reducing inflammation through the inhibition of various inflammatory mediators. They are classified pharmacologically as anti-inflammatory agents.

Investigated diseases

Severe Cardiac Inflammation – This condition involves significant inflammation of the heart muscle, which can affect the heart's ability to pump blood effectively. It may result from infections, autoimmune responses, or exposure to certain toxins. As the inflammation progresses, it can lead to symptoms such as chest pain, fatigue, and shortness of breath. Over time, the heart muscle may weaken, potentially leading to complications like heart failure or arrhythmias. The severity and progression of symptoms can vary widely among individuals. Monitoring and managing the inflammation are crucial to prevent further heart damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504169-22-02Protocol codeMYTHSEstimated enrolment121 patientsSponsorASST Grande Ospedale Metropolitano Niguarda

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