Evaluation of Methylprednisolone and Prednisone in Adult Patients with Acute Myocarditis and Reduced Heart Function

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What is this study about?

This study focuses on patients with acute myocarditis, a condition where the heart muscle becomes inflamed, leading to reduced heart function. The research specifically looks at cases where the condition has been confirmed through cardiac magnetic resonance imaging or tissue examination of the heart muscle. The study will test whether treatment with corticosteroid medications can help improve heart function and prevent serious heart-related complications.

The treatment being studied involves two medications: methylprednisolone, which is given through a vein for three days, followed by prednisone tablets taken by mouth. Some patients will receive these medications, while others will receive a placebo. All patients will continue to receive standard heart failure treatment throughout the study. The main purpose is to determine if this combination of corticosteroid medications can help improve heart function and prevent major heart-related events over a six-month period.

During the study, doctors will monitor the heart’s pumping ability and overall function using various heart tests. They will also track any heart-related complications that occur, such as hospital stays for heart problems, heart rhythm disturbances, or the need for heart support devices. The study will also look at how well patients tolerate the treatment and its effect on their quality of life.

1 Initial treatment phase – day 1 to 3

You will receive either methylprednisolone or placebo through an intravenous line (a small tube inserted into your vein)

The medication or placebo will be given as an injection or infusion

This phase lasts for three consecutive days

2 Oral medication phase

Following the initial treatment, you will receive either prednisone tablets or placebo tablets to take by mouth

The tablets will be 20 mg in size and can be split if needed

3 Heart function monitoring

Your heart function will be regularly checked using ultrasound imaging of your heart (echocardiography)

The doctors will measure your heart pumping strength and heart muscle movement

These measurements will be compared between the start of the study and after 6 months

4 Quality of life assessment

You will complete a questionnaire about how heart failure affects your daily life

This questionnaire is called the Minnesota Living with Heart Failure Questionnaire

5 Six-month follow-up

The main evaluation will occur 6 months after starting treatment

Doctors will check for any major heart-related events that occurred during this period

Your heart function will be measured again to compare with initial readings

The study will monitor if you experienced any side effects from the treatment

Who Can Join the Study?

  • Must be at least 18 years old
  • Must provide written informed consent to participate in the study
  • Must be enrolled in the French healthcare system or have other social protection coverage (except State Medical Aid)
  • Must have active myocarditis confirmed by all of these:
    • At least one of these symptoms: chest pain, heart failure, fainting, serious heart rhythm problems, survived cardiac arrest, heart-related shock, or specific heart-related electrical changes
    • Elevated heart protein (troponin) levels at least 1.5 times above normal
    • Confirmation through either heart imaging (Cardiac Magnetic Resonance) or heart tissue sample analysis
  • Must have reduced heart function shown by either:
    • Heart pumping capacity (LVEF) less than 50%, or
    • Abnormal heart muscle movement (GLS) less than -16%
  • Must have normal heart arteries (no blockages greater than 50%) confirmed by either:
    • Heart artery examination (coronary angiography), or
    • Special heart CT scan within the past year

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Previous history of heart failure (heart’s reduced ability to pump blood)
  • Current pregnancy or breastfeeding
  • Known allergies to methylprednisolone or prednisone (medications used in the study)
  • Active infections that require antibiotic treatment
  • History of autoimmune diseases (conditions where the immune system attacks healthy cells)
  • Recent heart attack (myocardial infarction) within the past 30 days
  • Inability to undergo cardiac magnetic resonance imaging (CMRi)
  • Current participation in other clinical trials
  • Severe kidney or liver disease
  • Uncontrolled diabetes (high blood sugar levels)
  • History of chronic steroid use
  • Mental conditions that may affect ability to provide informed consent
  • Active cancer or ongoing cancer treatment
  • Inability to take oral medications

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier General De Bastia Bastia France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis La Rochelle France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Saint Joseph Marseille France
Centre Hospitalier Universitaire De Nice Nice France
Groupe Hospitalier Bretagne Sud Lorient France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Hopital Beaujon Clichy France
Nouvelle Clinique de Tours Plus St Gatien Alliance par abreviation NCT St Gatien + Alliance ou NCT+ Saint-Cyr-Sur-Loire France
Cbdnfr Hhgxghsspwv Itmdvbrnxnmja Lp Rnqyabdjniebyupfz Monfermeil France
Abwohguuxe Prqlibmm Hfjnjsnk Du Mcqcdwlms Marseille France
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Gdycsp Hhennjoscwr Ukeoymxyiqcod Pslwm Pxctnqzpzeh Eb Nrmiiifuavyk Paris France
Swescyd Dogyaogbavgbsnsycpyv Da Cztbsv Cjupjcnalyhdh Db Nvoc St Denis France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.03.2025

Trial locations

Methylprednisolone
This is a powerful anti-inflammatory medication given through an intravenous (IV) injection. It belongs to a group of medicines called glucocorticoids, which help reduce inflammation in the body. In this trial, it’s used to treat acute myocarditis (inflammation of the heart muscle) in patients with reduced heart function.

Prednisone
This is an oral steroid medication (taken by mouth) that also belongs to the glucocorticoid family. It works similarly to methylprednisolone by reducing inflammation in the body. In this trial, it’s used as a follow-up treatment after the initial IV treatment for patients with myocarditis.

Both medications are being tested alongside standard heart failure therapy to see if they can improve heart function and prevent major cardiovascular events in patients with acute myocarditis.

Acute Myocarditis – An inflammatory condition affecting the heart muscle (myocardium). The inflammation can occur suddenly and may weaken the heart muscle, affecting its ability to pump blood effectively. It often results in reduced left ventricular function, which means the main pumping chamber of the heart works less efficiently. The condition can lead to changes in the heart’s electrical system and affect its normal rhythm. Myocarditis can cause the heart muscle to become enlarged and weakened, a condition that may be temporary or persist over time. The condition can be detected through specialized heart imaging or by examining small samples of heart tissue.

Left Ventricular Dysfunction – A condition where the left ventricle, the heart’s main pumping chamber, doesn’t work as effectively as it should. The heart muscle becomes weakened and cannot contract with enough force to pump blood efficiently to the rest of the body. This condition is often measured by the left ventricular ejection fraction (LVEF), which shows how much blood the heart pumps out with each contraction. The heart may also show abnormal movement patterns in its walls, measured by something called Global Longitudinal Strain.

Trial ID:
2024-510602-90-00
Protocol code:
APHP230855
NCT ID:
NCT06522100
Trial Phase:
Therapeutic confirmatory (Phase III)

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