Assistance Publique Hopitaux De Marseille
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Marseille, France
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Evaluation of Methylprednisolone and Prednisone in Adult Patients with Acute Myocarditis and Reduced Heart Function
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What is this trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
10 criteria
- 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 trial?
15 criteria
- 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
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CHRU De Nancy
ResponsiveVandoeuvre Les Nancy, FranceCentre Hospitalier Intercommunal Le Raincy-Monfermeil
VerifiedMonfermeil, France
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Investigated drugs
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.
What is already known about the treatment
Methylprednisolone
A potent glucocorticoid medication administered intravenously for three days in the treatment of acute myocarditis with severe left ventricular dysfunction. This steroid works by suppressing inflammation and immune responses in heart tissue, helping to reduce damage to the heart muscle. It belongs to the corticosteroid class of medications and is commonly used in various inflammatory conditions, with specific application in this trial for treating inflammation of the heart muscle.
Prednisone
An oral glucocorticoid medication used as a follow-up treatment after intravenous methylprednisolone in patients with acute myocarditis. This steroid medication works by reducing inflammation and suppressing the immune system's response, helping to manage ongoing heart muscle inflammation. It belongs to the corticosteroid class of medications and is administered in tablet form, making it suitable for longer-term treatment after the initial acute phase.
Investigated diseases
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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510602-90-00Protocol codeAPHP230855Estimated enrolment420 patientsSponsorAssistance Publique Hopitaux De Paris
sourced from the EU Clinical Trials Register and site verification
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