Study on Methylprednisolone and Human Normal Immunoglobulin for Treating Fulminant Myocarditis in Patients

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What is this study about?

This clinical trial is focused on studying a condition called fulminant myocarditis, which is a severe inflammation of the heart muscle that can lead to heart failure. The study is testing the effectiveness of two treatments: methylprednisolone, a type of corticosteroid that reduces inflammation, and human normal immunoglobulin (IVIG), which is a blood-derived product that helps the immune system. These treatments will be compared to a placebo to see how well they work in treating this condition.

The purpose of the study is to evaluate the effectiveness of these treatments in improving the health of patients with fulminant myocarditis. Participants in the study will receive either the active treatments or a placebo. The study will monitor the participants over a period of 28 days to assess outcomes such as survival, the need for heart transplantation, or the use of devices that assist heart function. The study will also track the number of days participants are alive without needing additional heart support.

Throughout the study, participants will receive the treatments intravenously, meaning the medication will be administered directly into a vein. The study aims to gather information on how these treatments affect heart function and overall health, including any side effects that may occur. The results will help determine the best approach to treating fulminant myocarditis and improving patient outcomes.

1 randomization

Upon joining the study, randomization occurs. This means being assigned to one of the treatment groups by chance. This process ensures that each participant has an equal opportunity to receive any of the treatments being tested.

2 treatment administration

The treatment involves the administration of medications through an intravenous route. This means the medications are given directly into a vein.

The medications used in the trial include methylprednisolone, human normal immunoglobulin (IV), and glucose. The specific dosage and frequency of administration are determined by the study protocol and may vary depending on the group assigned during randomization.

3 monitoring and assessments

Throughout the trial, regular monitoring and assessments are conducted to evaluate health status and response to treatment.

Assessments include measuring heart function, checking for side effects, and monitoring levels of certain proteins in the blood that indicate heart stress or damage.

4 follow-up evaluations

Follow-up evaluations occur at specific intervals, such as day 28, day 60, and day 90. These evaluations help determine the effectiveness of the treatment and monitor any long-term effects.

The evaluations include checking for survival, heart function, and any need for additional heart support devices or procedures.

5 final assessment

A final assessment is conducted to gather comprehensive data on the treatment’s impact. This includes a detailed review of heart function and any side effects experienced during the trial.

The final assessment helps in understanding the overall benefits and risks associated with the treatment.

Who Can Join the Study?

The patient must have fulminant myocarditis, which is a severe inflammation of the heart muscle. This condition should have started less than one month ago.
The patient must be experiencing hemodynamic compromise, which means their heart is not pumping blood effectively, leading to a condition called cardiogenic shock or an electrical storm, which is a severe heart rhythm problem.
The patient must have elevated plasma cardiac troponin levels, which are more than twice the normal value. Troponin is a protein released when the heart muscle is damaged.
The patient must need hemodynamic support, such as inotropes (medications that help the heart pump better) or temporary mechanical circulatory support (machines that help circulate blood), for less than 72 hours. This should not be due to a blockage in the heart’s blood vessels or other existing heart muscle diseases.
For patients aged 40 or older, a coronary angiogram (a test to check the heart’s blood vessels) should be done if myocarditis has not been confirmed by a tissue sample.
The patient, a close relative, or a legal representative must sign an informed consent form. This means they agree to participate in the study after understanding the details and risks.
If the patient is an adult and unable to give consent, the study can start without it, but consent will be obtained as soon as possible.
If the patient is a minor (under 18), the study can start without the legal representative’s consent, but it will be obtained as soon as possible.
The patient must be registered with social security (except for AME, which is a specific type of health coverage).

Who Cannot Join the Study?

Patients with fulminant myocarditis cannot participate. This is a severe and sudden inflammation of the heart muscle.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not part of the specified clinical trial groups cannot participate. The specific group is not detailed here.
Both male and female patients are considered, but if a patient does not meet other criteria, they cannot participate.
Patients who are part of a vulnerable population cannot participate. This refers to groups who may need special protection in research, like children or those unable to consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Hospital Foch	Suresnes	France
Hopital Beaujon	Clichy	France
Cfph Dz Nxlsf	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.10.2024

Trial locations

Investigated drugs:

Corticosteroids are medications used to reduce inflammation in the body. In this trial, they are given in high doses, known as pulse bolus, to quickly control severe inflammation in the heart, which is a condition called fulminant myocarditis. The goal is to improve heart function and reduce the need for more invasive treatments.

Immunoglobulins (IVIG) are a therapy made from antibodies that help the immune system fight infections and other diseases. In this trial, they are used alongside corticosteroids to see if they can provide additional benefits in treating fulminant myocarditis by further supporting the immune system and reducing inflammation in the heart.

Investigated diseases:

Myocarditis

Fulminant myocarditis – This is a severe and sudden inflammation of the heart muscle, often leading to rapid deterioration of heart function. It typically begins with flu-like symptoms such as fever, fatigue, and muscle aches, followed by chest pain and shortness of breath. As the condition progresses, it can cause a significant decrease in the heart’s ability to pump blood, leading to symptoms of heart failure. Patients may experience rapid or irregular heartbeats, swelling in the legs, and difficulty breathing. The condition can escalate quickly, requiring urgent medical attention to support heart function.

Trial ID:

2023-506599-28-01

Protocol code:

APHP220808

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Methylprednisolone and Human Normal Immunoglobulin for Treating Fulminant Myocarditis in Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?