Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Randomised placebo controlled clinical trial of efficacy of MYOcardial protection in postacute inFLAMmatory cardiac involvEment due to COVID-19 (MYOFLAME-19)

This research, called MYOFLAME-19, is an important study for people who have had heart inflammation because of COVID-19. We want to find out if two medicines, prednisolone and losartan, can help protect the heart and improve its function. Some participants will receive one of these active drugs, while others will get a placebo (a dummy pill) to compare the effects. We'll use special heart scans called Cardiovascular Magnetic Resonance imaging (CMR) to measure changes in heart pumping ability and other heart health markers. The study aims to see if these treatments can lead to better long-term heart health and fewer complications for people recovering from COVID-related heart problems.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Goethe University Frankfurt

Enrolment target

280

Start

18 Oct 2024

Inflammatory cardiovascular involvement due to COVID-19 defined by Cardiovascular magnetic resonance imaging

What is this study about?

When someone gets COVID-19, sometimes it can lead to inflammation, or swelling, in different parts of the body, including the heart. This heart inflammation can cause problems with how well the heart pumps blood and may lead to lasting issues. This study is designed to look into new ways to protect the heart after this kind of inflammation.

Researchers are testing two existing medicines: prednisolone and losartan. Prednisolone is a type of steroid that can reduce inflammation, while losartan is a blood pressure medicine that also has protective effects on the heart. The study wants to see if either of these drugs can help the heart recover better and improve its function in people who have experienced COVID-related heart problems. Half of the participants will receive one of the active medicines, and the other half will get a placebo (a pill that looks like the medicine but contains no active drug). This helps doctors understand if the drugs are truly making a difference.

To see how well the treatments are working, special heart scans called Cardiovascular Magnetic Resonance imaging (CMR) will be used. These scans provide detailed pictures of the heart and help measure how well it's pumping and if there's any remaining damage or inflammation. The main goal is to see if these medicines can help improve the heart's pumping ability (measured as LVEF) after 16 weeks, compared to those who received the placebo. The study also looks at other aspects of heart health, symptoms, and long-term outcomes for up to a year.

Key takeaways

This study aims to find better ways to protect hearts affected by COVID-19.
It tests two existing medicines: prednisolone and losartan.
Heart function and health are checked using special scans (CMR).
Some participants will receive a dummy pill (placebo) for comparison.
The study lasts about 16 weeks, with a follow-up at one year.
You'll get closer medical monitoring if you take part.

Who may be eligible?

This study is open to both men and women, aged 18 years and older, who have experienced inflammation in their heart linked to COVID-19. Doctors will use special detailed heart scans (called Cardiovascular Magnetic Resonance imaging) to confirm that this heart inflammation is present.

There might be other specific health conditions or medications that could prevent someone from joining, as is common in medical studies to ensure safety and that the results are clear. Your doctor or the study team will go through all the details with you carefully to see if this study is a good fit.

The most important thing is that you have been diagnosed with heart involvement due to COVID-19, as confirmed by these specific heart scans.

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 had heart inflammation linked to COVID-19?
Has a doctor confirmed your heart condition using special MRI scans (CMR)?
Are you able to attend regular clinic visits for tests and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full health check to make sure the study is right for you. If you qualify, you would be randomly assigned to receive either one of the study medications (prednisolone or losartan) or a placebo, which looks the same but contains no active medicine. Neither you nor your study doctor will know which you are receiving, which helps make the results fair.

You would take a daily study medicine, and your health would be monitored closely. This would involve a number of visits to the clinic over a period of about 16 weeks, where you would have follow-up heart scans (CMR), other heart tests, blood tests, and discussions about how you are feeling. You might also be asked to keep a simple diary of your symptoms or when you take your medication. There will also be a follow-up after one year to check on your overall health. The total duration of active participation will be around 16 weeks, with a final check-in at one year.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer medical monitoring and potentially receive a treatment that could improve your heart health after COVID-19. However, there's no guarantee the treatment will work for you, and there's a chance you might receive a placebo. Both prednisolone and losartan can have side effects, which the study team will explain in detail. You might also experience side effects from the tests and procedures involved. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Austria
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Unverified
Germany

Common questions

What is a 'placebo'?

A placebo is a 'dummy' pill that looks like the real medicine but contains no active drug. It helps us see if the actual medicine is truly working, or if improvements are due to other factors.

What is CMR?

CMR stands for Cardiovascular Magnetic Resonance. It's a special type of scan that uses magnets and radio waves to create detailed pictures of your heart, helping doctors see how well it's working.

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

No, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This is called 'blinding' and helps ensure the study results are fair and unbiased.

How long will I be in the study for?

The main part of the study where you take medication and have tests will last about 16 weeks. There will also be a follow-up phone call or visit after one year to check on your long-term health.

What are the medicines being tested?

The medicines are prednisolone, a steroid that reduces inflammation, and losartan, a blood pressure medicine that also helps protect the heart.