Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Use of Methylprednisolone Sodium Succinate for Treating Patients with Acute Myocarditis and Mildly Reduced Heart Function

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 where the heart muscle becomes inflamed, which can affect the heart's ability to pump blood effectively. The study will use a treatment called Solu-Medrone, which is a type of medication known as a corticosteroid. Corticosteroids are often used to reduce inflammation in the body. In this study, Solu-Medrone will be given as an injection into the bloodstream. Some participants will receive this treatment, while others will receive a placebo, which looks like the treatment but does not contain the active medication.

The purpose of the study is to see if the corticosteroid treatment can improve heart function in patients with acute myocarditis. Participants will be randomly assigned to receive either the Solu-Medrone treatment or the placebo. The study will last for a few days, during which the heart's function will be monitored using tests like an echocardiogram, which is an ultrasound of the heart. This will help doctors see if the treatment is effective in improving the heart's ability to pump blood.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to observe any changes in their condition. The study aims to provide valuable information on whether corticosteroid therapy can be a beneficial treatment for patients with acute myocarditis, potentially leading to better outcomes for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have signed an informed consent form. This form confirms understanding of the study and agreement to participate.

    Eligibility criteria include being between 18 and 69 years old, having certain heart function measurements, and showing signs of myocarditis.

  2. Step 2

    Randomization

    The patient is randomly assigned to receive either the standard therapy or the therapy involving corticosteroids.

    This step occurs within 120 hours of hospital admission.

  3. Step 3

    Treatment administration

    The patient receives Solu-Medrone 125 mg and sodium chloride through an infusion. This is a solution for injection.

    The treatment aims to improve heart function by increasing the left ventricular ejection fraction (LVEF).

  4. Step 4

    Monitoring and assessment

    Heart function is monitored through echocardiograms and other tests to assess the effectiveness of the treatment.

    The primary goal is to achieve an LVEF of 55% or more, or an increase of 10% in LVEF after 5 days.

  5. Step 5

    Follow-up evaluations

    Follow-up assessments occur at 6 months and 2 years to evaluate heart function and overall health.

    These assessments include cardiac magnetic resonance imaging (CMRI) and quality of life questionnaires.

  6. Step 6

    Completion of the study

    The study is estimated to end by May 2028.

    Final evaluations will determine the long-term effects of the treatment on heart function and patient health.

Who can join the trial?

8 criteria

  • Must be between 18 and 69 years old.
  • Have a heart function measurement called LVEF (Left Ventricular Ejection Fraction) less than 50% and a heart size measurement called LV-EDD (Left Ventricular End-Diastolic Diameter) less than 56 mm on an ultrasound of the heart.
  • Have increased levels of a heart-related protein called troponin, which is three times higher than the normal upper limit at the time of joining the study.
  • Have symptoms suggesting heart inflammation, known as myocarditis, that started within 3 weeks before joining the study.
  • For participants aged 46 and older, heart artery disease must be ruled out using a special heart X-ray called a coronary angiogram, unless myocarditis is confirmed by a tissue test.
  • Must join the study within 120 hours (5 days) of being admitted to the hospital.
  • A heart tissue test called an endomyocardial biopsy (EMB) is not required before joining the study, and the decision to perform it is up to the local medical team.
  • Must have willingly signed a consent form, which has been approved by an Ethics Committee or review board, after the study details have been explained and any questions have been answered.

Who cannot join the trial?

1 criterion

  • Patients with **acute myocarditis** cannot participate. This is a condition where the heart muscle becomes inflamed suddenly.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Corticosteroid Therapy is used in this trial to treat patients with acute myocarditis. It is administered intravenously, meaning it is given directly into a vein. The goal of this therapy is to reduce inflammation in the heart muscle, which can help improve heart function. In this study, the effectiveness of corticosteroid therapy is being compared to standard treatment to see if it can better improve the heart's ability to pump blood.

What is already known about the treatment

Corticosteroid Therapy – This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating acute myocarditis, particularly in patients with a mildly reduced left ventricular ejection fraction. The main therapeutic indication is to improve heart function by increasing the left ventricular ejection fraction. At the molecular level, corticosteroids work by reducing inflammation and modulating the immune response, which can help alleviate symptoms of myocarditis. They are classified pharmacologically as anti-inflammatory and immunosuppressive agents.

Investigated diseases

Acute Myocarditis – Acute myocarditis is an inflammation of the heart muscle, often caused by viral infections, autoimmune diseases, or exposure to certain toxins. This condition can lead to a reduction in the heart's ability to pump blood effectively, resulting in symptoms such as chest pain, fatigue, and shortness of breath. The inflammation can disrupt the heart's electrical system, causing arrhythmias or irregular heartbeats. In some cases, the heart muscle may become weakened, leading to heart failure. The progression of acute myocarditis can vary, with some individuals recovering fully while others may experience persistent heart issues. Monitoring and supportive care are essential to manage symptoms and prevent complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-501547-33-01Protocol codeMYTHSMR2023-07Estimated enrolment205 patientsSponsorAntwerp University Hospital

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.