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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliera Specialistica dei Colli – Ospedale Monaldi Naples Italy
Medical University Of Vienna Vienna Austria
Medizinische Universitaet Innsbruck Innsbruck Austria
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain

Other Sites

Site Name City Country Status
Centro Cardiologico Monzino S.p.A. Milan Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Alessandro Manzoni Hospital Lecco Italy
Universita Degli Studi Di Brescia Brescia Italy
U.O.C. Cardiologia, Azienda Ospedaliera San Camillo-Forlanini Rome Italy
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Turin Italy
Hospital Universitario Virgen De La Victoria Malaga Spain
Università degli Studi di Firenze-Azienda Ospedaliero Universitaria Careggi SC di Oncologia Medical Florence Italy
Complexo Hospitalario Universitario A Coruña (CHUAC), A Coruña A Coruna Galicia Spain
Murxdrt Ueyvbwdblv oq Glfu Graz Austria
Hqkdz axp Lwdq Cfrbvvh Hnzexefb Ujfdbziuyj Hsqrfmag Helsinki Finland
Uankzvthdwnxb kfqcglys ctjifv Lyhzigomd Ljubljana Slovenia
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Fyyeuwnzwm Gbeoxghg Mtlvekihqkg Spp Cukyyaa Hrtgaqwsc Cdz Rdwqaibg Artk Pisa Italy
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Peguhhzs Orrlsexlovg Uxmzptipugawg &hpmuqapnixk Mlcrz dpjpi Mzkmmxcscyxkhcekdtd Udine Italy
Pnblakoowwk Sqgacsgoyiespszki Bologna Italy
Ugletjnyff Hypkrvxyf Lssrck Leuven Belgium
Jqlbq Horemrto Hasselt Belgium
Mahcnal Uycnplgpnl Srf Abntrsfkvlam Umangmuwsa Hbohlxpf Bupuf Crpnyhy Brno Czechia
Ccdxgmb Utskrbvihv id pqfyvq azf Gingaid Usdtjzrgbr Hxkedckj Prague Czechia
Igjkqwaem fwl Czejnnjf ard Evejuclgntbz Mmyrienz Prague Czechia
Ahqismp Ofnvytddxqd Ukijcrmmudkyu Skobas Siena Italy
Hqefargs Dz Lw Szvzq Ckdl I Skif Pwx Barcelona Spain
Usjymbkcsi On Ahvqixv Edegem Belgium
Amhkuqp Ogmobdaawem Pwph Gzbjwmij Xnkwt Bergamo Italy
Owxentrdmiqemmqulkprlfibnn Aalst Belgium
Hhhmwbtk Vjjg dhnqfogg Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
11.06.2024
Belgium Belgium
Recruiting
11.06.2024
Czechia Czechia
Recruiting
11.06.2024
Finland Finland
Not yet recruiting
11.06.2024
Italy Italy
Recruiting
11.06.2024
Slovenia Slovenia
Recruiting
11.06.2024
Spain Spain
Recruiting
11.06.2024
Sweden Sweden
Not yet recruiting
11.06.2024

Trial locations

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.

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 ID:
2023-504169-22-02
Protocol code:
MYTHS
NCT ID:
NCT05150704
Trial Phase:
Therapeutic confirmatory (Phase III)

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