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Study of prednisolone and losartan in patients with heart inflammation after COVID-19 infection

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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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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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Investigated drugs

  • Prednisolone

    is a steroid medication that reduces inflammation and suppresses the immune system. In this trial it is used to calm the heart’s inflammatory response that can occur after COVID‑19, helping to protect heart muscle cells from damage.

  • Losartan

    is a medication that blocks a hormone called angiotensin II, which can cause blood vessels to tighten and the heart to remodel after injury. In the study it is given to help prevent harmful changes in the heart’s structure and to support overall heart function while the anti‑inflammatory drug works.

What is already known about the treatment

  • Prednisolone

    This medication is taken by mouth as a tablet that is swallowed whole with water. It is an approved corticosteroid that has been used for many years to treat inflammation and immune‑related conditions. It works by attaching to glucocorticoid receptors inside cells, which then lowers the production of inflammatory signals. Pharmacologically it is classified as a glucocorticoid anti‑inflammatory drug.

  • Losartan potassium

    This drug is taken orally as a film‑coated tablet that is swallowed with water. It is an approved medicine commonly used to treat high blood pressure and protect the heart. It blocks the angiotensin II type 1 receptors, preventing the hormone from narrowing blood vessels and raising blood pressure. Pharmacologically it belongs to the class of angiotensin II receptor blockers (ARBs).

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.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516463-84-00Protocol codeMYOFLAME-19Estimated enrolment280 patientsSponsorGoethe University Frankfurt

sourced from the EU Clinical Trials Register and site verification

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