AuthorisedTherapeutic exploratory (Phase II)Interventional

Pulse corticosteroids or/and Immunoglobulins to treat fulminant Myocarditis: a double-blind randomized controlled adaptive trial (The CORIUM study)

This research study, called CORIUM, is designed to find better ways to treat a very serious heart problem known as fulminant myocarditis. This condition means the heart muscle suddenly becomes inflamed and weakened. The study is testing two types of medicines, corticosteroids and immunoglobulins, given either alone or together, to see if they can help people recover. Researchers want to know if these treatments can reduce the risk of death or needing a heart transplant, and help patients get better faster, without needing a special heart support machine. It's a phase II study, meaning it's an early-stage trial looking closer at safety and how well these treatments work.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

120

Start

09 Jan 2025

Fulminant myocarditis

What is this study about?

This study is called CORIUM, and it's trying to find the best way to treat a serious heart condition called fulminant myocarditis. This is when the heart muscle suddenly becomes very inflamed and weak, making it hard for the heart to pump blood effectively. It's a critical situation that needs quick and effective treatment.

The researchers are looking at two types of medicines that might help: corticosteroids and immunoglobulins. Corticosteroids are powerful anti-inflammatory drugs, while immunoglobulins are special proteins that can help the body's immune system. The study wants to see if giving these medicines, either separately or combined, can help patients recover better. For example, they are looking to see if these treatments can reduce the chance of needing a heart transplant or special heart support machines, and if people can return to health more quickly.

This is a 'Phase II' study, which means it's an early but important step. It's designed to explore how well these treatments work and to check their safety in people with fulminant myocarditis. The goal is to gather enough information to decide if these treatments should be studied further in larger trials, potentially leading to new standard treatments for this condition.

Key takeaways

Tests new treatments for a serious heart condition called fulminant myocarditis.
Compares corticosteroids and immunoglobulins to see if they improve recovery.
Aims to reduce the need for heart transplants and improve survival rates.
It's a 'Phase II' study, meaning it's an early step in testing new treatments.
Open to adults aged 18 and over, both men and women.
Participants are closely monitored for health improvements and potential side effects.

Who may be eligible?

To be able to join this study, you must be at least 18 years old. There is no upper age limit, meaning older adults can participate as well. The study is open to both men and women.

Basically, if you are an adult diagnosed with fulminant myocarditis, you might be suitable for this research. The medical team will carefully check other specific health details to make sure the study is a safe and appropriate option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with fulminant myocarditis?
Are you able to receive medicines given directly into your vein?
Are you able to attend follow-up appointments?
Are you comfortable with the possibility of receiving different treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to receive one of the study treatments: either a corticosteroid, immunoglobulin, or a combination of both. These medicines will be given as infusions (into a vein). You won't know which specific treatment you're getting, nor will your doctors, as this helps ensure the results are unbiased. The study treatments will likely be given while you are staying in the hospital for your condition.

Doctors will carefully monitor your health and recovery over a period of time. This will involve regular check-ups, blood tests, and heart scans (like echocardiograms) to see how your heart is responding. They'll also keep track of any side effects you might experience. The main assessments will focus on your health 28 days after starting treatment, and continuing up to 90 days. The total duration of active follow-up for the study will vary, but key checks are at 28 days, 60 days, and 90 days, with some longer-term assessments at 6 months, such as heart scans.

Potential risks and benefits

Taking part in this study might mean you receive a new treatment that could potentially help your heart condition improve faster or lead to fewer complications compared to standard care. However, as with any medical treatment, there are potential risks and possible side effects associated with corticosteroids and immunoglobulins, which your doctor will discuss in detail. Your health will be closely monitored to quickly address any issues. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is fulminant myocarditis?

It's a very serious and sudden inflammation of your heart muscle, making your heart weak and unable to pump blood properly.

What are corticosteroids and immunoglobulins?

Corticosteroids are strong anti-inflammatory medicines, and immunoglobulins are special proteins from blood that help your immune system.

Why is this study 'double-blind'?

Double-blind means neither you nor your doctors will know which specific treatment you're getting, which helps make the study results more reliable and fair.

Will I have to stay in the hospital for the whole study?

You will likely be in the hospital for the initial treatment and close monitoring, but the follow-up checks can happen even after you leave the hospital.

Can I stop being part of the study at any time?

Yes, absolutely. You can withdraw from the study at any point without it affecting your medical care.