Not recruiting

Study of Prednisolone and Losartan in patients with heart inflammation after COVID-19 infection

Verified siteRegistered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on inflammatory cardiovascular involvement that occurs after COVID-19 infection. The study aims to evaluate the effectiveness of a combined treatment approach using two medications: prednisolone (a steroid that reduces inflammation) and losartan (a medication that helps protect the heart) compared to placebo in patients who have heart inflammation following COVID-19 infection.

The condition being studied is detected through special heart imaging called Cardiovascular Magnetic Resonance imaging, which can show inflammation in the heart tissue. The treatment involves taking tablets of prednisolone and losartan by mouth for 16 weeks. Some participants will receive the actual medications, while others will receive placebo tablets that look the same but contain no active medication.

The study will measure how well the heart functions before and after treatment using detailed heart imaging. This will help determine if the combination of medications can reduce heart inflammation and improve heart function in people who have developed heart problems after COVID-19 infection. The treatment's safety will also be monitored throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
A cardiovascular magnetic resonance (CMR) scan will be performed to confirm heart inflammation related to COVID-19
The scan will measure your heart function and look for signs of inflammation in the heart tissue
Step 2
Treatment start
You will receive either:
- Active treatment: prednisolone tablets (starting with 10 mg, then 5 mg) and losartan tablets (starting with 12.5 mg, increasing to 25 mg), or
- Placebo tablets (containing inactive ingredients)
Neither you nor your doctor will know which treatment you are receiving
Step 3
Treatment duration
The treatment will continue for 16 weeks
You will need to take the medication as prescribed and keep a diary of your medication use
Step 4
Follow-up assessment
After 16 weeks, another CMR scan will be performed to measure changes in your heart
Additional tests will include:
- Exercise capacity test
- Heart muscle measurements
- Assessment of your symptoms
Step 5
Long-term follow-up
Your health status will be monitored for up to one year after treatment completion
The doctors will track any heart-related events or complications during this period

Who can join the trial?

9 criteria

Must be at least 18 years old
Must have had a confirmed COVID-19 infection more than 4 weeks ago
Must have ongoing or new symptoms that weren't present before COVID-19 infection (known as Post-acute COVID-19 Syndrome)
Must have evidence of heart inflammation on a special heart scan (Cardiovascular Magnetic Resonance imaging) showing at least one of these findings:
- Increased T1 measurements in heart tissue
- Increased T2 measurements in heart tissue
- Signs of scarring in the heart muscle or its surrounding tissue
- Heart pumping function between 45-50%
- Must be willing and able to follow all study procedures and protocol requirements
- Both men and women can participate

Who cannot join the trial?

15 criteria

Patients under 18 years of age
Active myocarditis (heart muscle inflammation) not related to COVID-19
Known allergies to any of the study medications
Pregnant or breastfeeding women
Severe kidney dysfunction (creatinine clearance less than 30 mL/min)
Active or chronic infections other than COVID-19
Presence of metal implants or devices that would interfere with cardiac magnetic resonance imaging (heart scan)
Severe heart rhythm abnormalities
History of severe allergic reactions
Current participation in other clinical trials
Unable to provide informed consent
Severe liver disease
History of recent heart attack or stroke (within last 3 months)
Uncontrolled high blood pressure
Active cancer or ongoing cancer treatment

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Goethe University Frankfurt
Verified
Frankfurt, Germany
Medical University Of Vienna
Verified
Vienna, Austria
Universitaetsklinikum Schleswig-Holstein AöR
Verified
Kiel, Germany

Trial locations

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Investigated drugs

Based on the provided trial data, I cannot extract specific medications as there are no medications clearly listed in the source data. While the trial title (MYOFLAME-19) and objective mention "immunosuppressive and antiremodelling therapy," the specific medications are not detailed in the provided information. Without explicit medication names, I cannot provide accurate descriptions of the treatments involved in this clinical trial. The trial appears to be comparing some form of combined therapy against placebo for treating COVID-19-related cardiac inflammation, but the specific medications used are not included in the source data.

What is already known about the treatment

Based on the provided clinical trial data, the trial involves a combined immunosuppressive and antiremodeling therapy, but specific medications are not listed in the source data. Without explicit medication names from the trial data, I cannot create medication descriptions in the requested format. The trial appears to be studying treatment for COVID-19-related cardiovascular inflammation, but the specific therapeutic agents are not disclosed in the provided information. If you could provide the specific medications being tested in this MYOFLAME-19 trial, I would be happy to create descriptions following the requested format.

Investigated diseases

COVID-19 Related Inflammatory Cardiovascular Disease - A condition that develops as a complication of COVID-19 infection, affecting the heart and blood vessels. The disease involves inflammation of the heart muscle and surrounding tissues, which can be detected through cardiovascular magnetic resonance imaging. This condition can affect the heart's ability to pump blood effectively and may cause changes in heart muscle tissue. The inflammation can impact both the left and right ventricles of the heart, potentially leading to changes in heart function. The condition may also affect the blood vessels, including the aorta, and can cause various cardiovascular symptoms.