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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Alessandro Manzoni Hospital Lecco Italy
Fondazione Toscana Gabriele Monasterio Pisa Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Jessa Ziekenhuis Hasselt Belgium
Gasthuiszusters Antwerpen Antwerp Belgium
University Medical Center Ljubljana Ljubljana Slovenia
Azienda USL Toscana Sud Est Arezzo Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Universita Degli Studi Di Brescia Brescia Italy
Ukppermgqj Oa Axsegiq Edegem Belgium
Aucopku Ovavxplazbs Pmnc Grihhrrb Xsmgq Bergamo Italy
Oockvrprjvurfoofdlnvxxfxoz Aalst Belgium
Hlhpkqrx Vaoa djhesmlq Barcelona Spain
Hbenamtp Ucayqbrxmusda dj A Cixzjy A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.03.2024
Italy Italy
Recruiting
01.03.2024
Slovenia Slovenia
Recruiting
01.03.2024
Spain Spain
Recruiting
01.03.2024

Trial locations

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.

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 ID:
2022-501547-33-01
Protocol code:
MYTHSMR2023-07
NCT ID:
NCT05974462
Trial Phase:
Human Pharmacology (Phase I) – Other

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