Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Myocarditis Therapy with IL-1 inhibitor (MYTH-1): a double-blind, phase IIa, placebo controlled, randomized clinical trial to evaluate the efficacy and safety of anakinra in addition to standard of care for the treatment of virus-negative myocarditis.

This research, called MYTH-1, is exploring a new medicine named anakinra to treat a heart problem called myocarditis. Myocarditis means your heart muscle is inflamed. This particular study is for people whose myocarditis has been confirmed by a heart biopsy and isn't caused by a virus. The main goal is to find out if adding anakinra to the standard treatments helps improve how well your heart pumps blood after two months. This is an early-stage study, using a careful approach where some people get the new medicine and others get a dummy medicine, to fairly compare the effects. It’s open to adults aged 18 and over, both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ospedale San Raffaele S.r.l.

Enrolment target

Start

16 Oct 2024

endomyocardial biopsy (EBM)-proven virus-negative myocarditis

What is this study about?

This study is called MYTH-1, and it's looking into a new way to treat a condition called myocarditis. Myocarditis means your heart muscle is inflamed. This can sometimes make your heart pump less effectively. In this study, we're focusing specifically on myocarditis that has been confirmed by a special test called an endomyocardial biopsy, and importantly, it's not caused by a virus. We know that viruses often cause myocarditis, but this study is for those cases where doctors can't find a viral cause.

The main aim of this study is to see if a medicine called anakinra, when given alongside the usual treatments you might receive, can help your heart pump better. Doctors will measure how well your heart is pumping, specifically looking at something called the Left Ventricular Ejection Fraction (LVEF), using an ultrasound scan of your heart after two months. This is an important measurement that tells us about your heart's strength.

This is a 'Phase II' study, which means it's an early step in testing a new treatment. We're carefully exploring if anakinra is both safe and effective. To make sure the results are fair, some participants will receive anakinra, and others will receive a 'placebo' – a dummy medicine that looks the same but contains no active drug. Neither you nor your doctors will know which one you are getting, and this unbiased approach helps us get the clearest picture of anakinra's effects. The study is important because it could lead to better ways to treat non-viral myocarditis.

Key takeaways

This study is testing a new medicine, anakinra, for a specific type of heart inflammation.
It aims to see if anakinra improves heart pumping in adults with non-viral myocarditis.
Participants will receive either anakinra or a dummy medicine, plus their usual care.
The study involves regular check-ups and heart scans over about two months.
It's an early-stage study to understand both safety and effectiveness.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you must be at least 18 years old – there's no upper age limit. The study welcomes all adult men and women.

Critically, your doctors must have found that you have myocarditis using a specific test called an endomyocardial biopsy. This test involves taking a tiny sample of your heart muscle. Also, tests must have shown that your myocarditis is not caused by a virus. This is a very specific type of heart inflammation that the study is focusing on.

There will be other detailed medical criteria that your doctor will check to make sure the study is a safe and suitable option for you. These might include things like your general health, other medical conditions, and medicines you are currently taking.

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?
Has a doctor confirmed you have myocarditis with a heart biopsy?
Have tests shown your myocarditis is NOT caused by a virus?
Are you able to attend regular hospital or clinic visits for tests and assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process. This is where doctors will check if you meet all the requirements. If you do, you would then begin the study treatments. You would receive either the study medicine (anakinra) or a dummy medicine, in addition to the standard care your doctor recommends for myocarditis. This medicine is typically given as an injection.

Throughout the study, you would have several visits to the hospital or clinic. These visits will involve various tests and assessments to monitor your heart health and general well-being. A key test will be a heart ultrasound (called a Trans Thoracic Echocardiography or TTE), which will be done at the start and again after about two months to see if your heart's pumping function has changed. There will also be blood tests to monitor your health and how you are responding to the treatment.

The main treatment period being looked at for heart function is two months. However, the study might involve follow-up visits after this period to ensure your continued safety and track long-term effects. The total duration of your involvement could vary, but the main assessment of heart pumping will be at the two-month mark.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new investigational treatment that might help your condition, which isn't yet widely available. You'll also receive careful monitoring from medical professionals. However, there are potential risks, including side effects from the study medication or the possibility that the treatment may not work for you. There could also be side effects from the procedures, like blood tests or biopsies. It's important to remember that you can decide to stop participating in 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
Italy

Common questions

What is myocarditis?

Myocarditis is an inflammation of your heart muscle. It can sometimes make your heart weaker and affect how well it pumps blood.

What is anakinra?

Anakinra is a medicine that helps to reduce inflammation in the body. This study is testing if it can help reduce the inflammation in the heart muscle in people with myocarditis.

What does 'double-blind' mean?

It means that neither you nor your study doctors will know whether you are receiving the active study medicine (anakinra) or a dummy medicine (placebo). This helps make the study fair and unbiased.

Why is it important that my myocarditis is 'virus-negative'?

This study is specifically looking at myocarditis that isn't caused by a virus. Treatments for viral and non-viral myocarditis can be different, so this study focuses on a particular type.

Will I still get my usual myocarditis care?

Yes, if you join this study, you will continue to receive the standard treatments for myocarditis that your doctors recommend, in addition to the study medicine or placebo.