AuthorisedTherapeutic confirmatory (Phase III)Interventional

COTAM - Use of glucocorticoids therapy in acute myocarditis with severe left ventricular dysfunction: a multicenter randomized controlled trial

This study, called COTAM, is investigating whether a steroid medicine, methylprednisolone, can help people who have a serious heart condition called acute myocarditis. Myocarditis means your heart muscle is inflamed. For this study, patients will have severe inflammation that affects how well their heart pumps. Researchers want to see if this medicine can improve heart function and prevent future serious problems like heart failure, repeated heart attacks, or the need for a heart transplant. Some people will receive the steroid, while others will get a dummy medicine (placebo). The study will follow people for six months to check their heart health and general well-being. This is a Phase III study, meaning it's a critical step in confirming the effectiveness and safety of the treatment.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

420

Start

20 Mar 2025

Patients presenting with acute myocarditis proven by cardiac magnetic resonance imaging (CMRi) or by histological evidence on endomyocardial biopsy (EMB)

What is this study about?

This research, known as the COTAM study, is all about finding the best way to help people who have a serious heart condition called acute myocarditis. Acute myocarditis happens when the heart muscle becomes inflamed, often due to an infection. In this particular study, they are focusing on people whose hearts are struggling to pump blood properly because of this inflammation. The main goal is to see if a type of steroid medication, specifically methylprednisolone, can help stop the heart from getting worse and improve its ability to pump.

To figure this out, some patients will receive the actual steroid medication, while others will get a 'dummy' treatment, known as a placebo. This comparison is really important because it helps the researchers understand if any improvements are truly due to the steroid or if they might have happened anyway. The research team will regularly check how well the heart is working, for example, using special scans and tests, over a period of six months.

The study will look at how many people experience significant heart-related problems, such as needing to go to the hospital for heart failure, having serious irregular heartbeats, or even needing a heart transplant. They will also carefully monitor changes in how effectively the heart pumps blood and how participants feel overall. This information will help doctors understand whether steroid treatment can make a significant difference to people recovering from severe acute myocarditis.

Key takeaways

This study investigates a steroid medicine for severe acute myocarditis.
It aims to improve heart function and prevent serious heart problems.
Some participants will receive the steroid, others a dummy medicine (placebo).
Heart health will be monitored for six months.
It's for adults aged 18 and over with confirmed acute myocarditis.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old – there's no upper age limit.

Both men and women can take part. The most important medical requirement is that you have a recently diagnosed condition called acute myocarditis. This diagnosis needs to be confirmed either by a special heart scan called cardiac magnetic resonance imaging (MRI) or by looking at a tiny sample of your heart muscle under a microscope (a biopsy).

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 recently been diagnosed with acute myocarditis?
Was your myocarditis confirmed by a special heart scan (MRI) or a heart muscle biopsy?
Are you experiencing severe issues with how your heart pumps blood?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be involved in receiving one of the study treatments – either methylprednisolone, which is a steroid given through an injection or infusion, or a placebo (a dummy medicine) given in the same way. You might also receive another steroid tablet called prednisone or its placebo.

The study involves regular check-ups and tests, such as heart scans (echocardiograms) and possibly blood tests, to see how your heart is responding to the treatment. These assessments will happen at different points, starting just before you begin (around day 2 before treatment) and continuing for up to six months after you start the treatment. During this time, the research team will also keep track of any health issues you might experience and how well you're feeling, including your quality of life. The total duration of active follow-up for the main study is six months.

Potential risks and benefits

Participating in this study might offer a potential benefit by receiving a treatment that could improve your heart function and prevent serious heart-related problems from severe acute myocarditis, though there's no guarantee the treatment will work for you. There are also potential risks, as with any medication, including side effects from the steroid treatments, such as increased risk of infection or changes in blood sugar. You might also experience discomfort from tests like injections or blood draws. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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 acute myocarditis?

Acute myocarditis is a condition where your heart muscle becomes inflamed, often making it harder for your heart to pump blood properly throughout your body.

What is a steroid and how might it help?

Steroids are powerful medicines that can reduce inflammation. In this study, researchers hope that reducing the inflammation in your heart might help it recover and work better.

What does 'placebo' mean?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers fairly compare if the real medicine is truly effective.

How long will I be followed in the study?

You will be followed and have your heart health checked regularly for about six months after you start the treatment.

Will I know if I'm getting the real medicine or the placebo?

No, during the study, neither you nor your doctors will know whether you are receiving the active steroid medicine or the placebo. This is to keep the study fair and unbiased.