Clinical Trials for Myocarditis: Current Research and Treatment Options
This article provides information about 8 ongoing clinical trials investigating new treatments for myocarditis, a condition where the heart muscle becomes inflamed. These trials are being conducted across multiple countries in Europe and are testing various medications including corticosteroids, anti-inflammatory drugs, and immune-modulating therapies to improve heart function and recovery in patients with different forms of myocarditis.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Finland
- France
- Study of Anakinra compared to placebo for treating acute myocarditis in children admitted to intensive care units
- Study on Colchicine for Reducing Heart Damage in Patients with Acute Myocarditis
- Study on Methylprednisolone and Human Normal Immunoglobulin for Treating Fulminant Myocarditis in Patients
- Study on the Effect of Cannabidiol (CardiolRx) on Heart Recovery in Patients with Acute Myocarditis
- Italy
- Poland
- Slovenia
- Spain
- Study on Ibuprofen vs. Conventional Treatment for Patients with Acute Myocarditis
- Study on the Use of Methylprednisolone Sodium Succinate for Treating Patients with Acute Myocarditis and Mildly Reduced Heart Function
- Study on the Safety and Effectiveness of Methylprednisolone Sodium Succinate and Sodium Chloride for Patients with Severe Cardiac Inflammation
Study of prednisone and azathioprine treatment in patients with virus-negative myocarditis or inflammatory heart muscle disease with reduced heart pump function
This trial is examining the effectiveness of combining two medications, prednisone and azathioprine, to treat inflammation of the heart muscle when no virus is present. The study specifically targets patients whose hearts are not pumping blood as effectively as they should, with a heart function measurement between 10-45%.
Main inclusion criteria: Participants must be between 18 and 65 years old with confirmed active inflammation or inflammatory heart muscle disease shown through heart tissue biopsy. They should have experienced no significant improvement despite at least three months of standard treatment. Women who can become pregnant must use effective birth control and have a negative pregnancy test. The heart tissue must test negative for heart-affecting viruses.
Main exclusion criteria: The study excludes individuals with viral inflammation, heart function below 10% or above 45%, those under 18 years old, and people with known allergies to prednisone or azathioprine. Pregnant or breastfeeding women, patients with active infections, autoimmune diseases, severe kidney or liver disease, recent heart attack within 30 days, or history of cancer in the past 5 years cannot participate.
Focus of the trial: The research aims to reduce inflammation in the heart muscle by suppressing the immune system response. Treatment lasts 12 months with medications taken as tablets by mouth, followed by another 12 months of monitoring. The study measures changes in heart function, specifically how well the heart pumps blood with each beat.
Investigational drugs: Prednisone is a corticosteroid that reduces inflammation by suppressing immune system activity. Azathioprine is an immunosuppressive medication that decreases the immune system’s activity, preventing it from attacking healthy heart tissue. Both medications work together to treat inflammation when no virus is causing the condition.
Study on Ibuprofen vs. Conventional Treatment for Patients with Acute Myocarditis
This trial compares the use of ibuprofen, a common anti-inflammatory drug, with paracetamol (a standard pain reliever) in treating acute heart muscle inflammation. The study focuses on patients whose hearts are still functioning relatively well.
Main inclusion criteria: Participants must be 18 years or older and hospitalized for confirmed acute inflammation with a heart pumping function of 50% or higher. They should not have acute heart failure or blocked heart arteries. The diagnosis must meet specific criteria using a special heart scan called cardiac magnetic resonance imaging, and participants must be able to provide informed consent.
Main exclusion criteria: Patients with other unrelated heart conditions, recent heart attack, severe kidney or liver disease, or those taking medications that might interfere with the study treatment cannot participate. Pregnant or breastfeeding women, individuals with allergies to ibuprofen or paracetamol, and those currently in another clinical trial are excluded.
Focus of the trial: The study evaluates whether ibuprofen is more effective than paracetamol in reducing heart muscle inflammation over a three-week treatment period. Participants undergo regular monitoring, with a follow-up heart scan at 6 months to measure changes in heart tissue damage using specialized imaging techniques.
Investigational drugs: Ibuprofen is a non-steroidal anti-inflammatory drug being tested to see if it can reduce inflammation in the heart muscle and improve recovery markers. Paracetamol serves as the comparison treatment, managing pain without the anti-inflammatory effects.
Study on the Use of Methylprednisolone Sodium Succinate for Treating Patients with Acute Myocarditis and Mildly Reduced Heart Function
This international study investigates whether corticosteroid therapy with Solu-Medrone can improve heart function in patients with acute inflammation and mildly reduced pumping ability. The medication is given through intravenous injection directly into the bloodstream.
Main inclusion criteria: Patients must be between 18 and 69 years old with a heart function measurement below 50% and increased troponin protein levels at least three times higher than normal. Symptoms suggesting heart inflammation should have started within 3 weeks before joining. Participants must enroll within 120 hours of hospital admission and provide signed informed consent.
Main exclusion criteria: The study specifically excludes patients with acute inflammation of the heart muscle.
Focus of the trial: The research compares corticosteroid treatment to placebo to determine if the medication can improve heart pumping function. The primary goal is to achieve a heart function measurement of 55% or more, or at least a 10% increase after 5 days of treatment. Follow-up assessments continue at 6 months and 2 years using cardiac magnetic resonance imaging and quality of life questionnaires.
Investigational drugs: Corticosteroid therapy is administered intravenously to reduce inflammation in the heart muscle. The medication works by suppressing the immune response and modulating inflammation, potentially helping to restore normal heart function.
Study of Anakinra compared to placebo for treating acute myocarditis in children admitted to intensive care units
This pediatric study evaluates whether Anakinra, a medication that blocks inflammatory proteins in the body, can help restore normal heart function in children with acute inflammation who are being treated in intensive care units.
Main inclusion criteria: Children between 3 months and 18 years old receiving intensive care for acute inflammation with reduced heart pumping function (below 50%) and elevated troponin T levels more than 1.5 times higher than normal can participate. Parents or legal guardians must provide signed informed consent, and children old enough to understand must also agree to participate.
Main exclusion criteria: Children under 1 month or over 18 years, those with known allergic reactions to Anakinra, active bacterial infections, severe kidney failure, current participation in other trials, weakened immune systems, chronic heart disease history, pregnancy, blood disorders, liver disease, or genetic disorders affecting the heart cannot participate.
Focus of the trial: The treatment involves daily subcutaneous injections of 100 mg Anakinra for 7 days, alongside standard medical care. Researchers monitor heart function through regular ultrasounds and blood tests at 24, 48, and 72 hours, with follow-up assessments at 7 days, 28 days, and up to 6 months to track recovery and potential side effects.
Investigational drugs: Anakinra is a biological medication that blocks interleukin-1, a protein causing inflammation. By suppressing inflammation, it may help improve heart muscle function in children with acute heart inflammation.
Study on Colchicine for Reducing Heart Damage in Patients with Acute Myocarditis
This trial investigates whether colchicine, an anti-inflammatory medication, can reduce heart muscle damage and improve overall heart health outcomes in patients with acute inflammation. The study monitors participants for approximately six months.
Main inclusion criteria: Participants must be between 18 and 65 years old with symptoms starting 21 days or less before enrollment. They should have chest pain, heart failure symptoms, or irregular heartbeats, with troponin levels higher than the 99th percentile. The diagnosis must be confirmed by cardiac magnetic resonance imaging, with no signs of blocked heart arteries verified through specialized imaging for patients over 40 with risk factors. Women of childbearing age must use effective contraception during treatment and for 1 month after.
Main exclusion criteria: Patients without confirmed diagnosis on cardiac imaging, those outside the specified age range, individuals unable to provide informed consent, or those considered part of vulnerable populations cannot participate.
Focus of the trial: The study compares colchicine to placebo over a six-month period, monitoring heart muscle damage through cardiac magnetic resonance imaging and tracking heart-related events such as heart failure or the need for medical procedures. Various health markers are assessed throughout the study.
Investigational drugs: Colchicine is an oral anti-inflammatory medication that works by inhibiting microtubule polymerization, which reduces inflammatory cell activity. The trial aims to determine if it can effectively reduce heart inflammation and improve patient outcomes.
Study on Methylprednisolone and Human Normal Immunoglobulin for Treating Fulminant Myocarditis in Patients
This trial studies the effectiveness of combining methylprednisolone, a corticosteroid, with human normal immunoglobulin (IVIG) compared to placebo in treating fulminant inflammation, a severe and rapid form of heart muscle inflammation that can lead to heart failure.
Main inclusion criteria: Patients must have fulminant inflammation starting less than one month ago with significant heart pumping problems causing cardiogenic shock or severe heart rhythm disturbances. Plasma cardiac troponin levels must be more than twice the normal value, and patients must need heart support medications or temporary mechanical devices for less than 72 hours. For patients 40 or older, a coronary angiogram should be performed if inflammation hasn’t been confirmed by tissue sample. Informed consent must be obtained from the patient, close relative, or legal representative.
Main exclusion criteria: Patients with fulminant inflammation cannot participate in this study.
Focus of the trial: The study monitors participants over 28 days to assess outcomes including survival, need for heart transplantation, or use of heart-assist devices. Treatments are administered intravenously, and the research evaluates how these medications affect heart function and overall health, including any side effects.
Investigational drugs: High-dose pulse bolus corticosteroids are used to quickly control severe inflammation in the heart. Immunoglobulins (IVIG), made from antibodies, are used alongside corticosteroids to provide additional immune system support and further reduce inflammation.
Study on the Safety and Effectiveness of Methylprednisolone Sodium Succinate and Sodium Chloride for Patients with Severe Cardiac Inflammation
This large international trial assesses the safety and effectiveness of high-dose pulse intravenous corticosteroid therapy using methylprednisolone sodium succinate (Solu Medrol) in patients with complicated or severe acute inflammation.
Main inclusion criteria: Participants must be between 18 and 69 years old with acute heart failure and suspected acute inflammation based on specific blood test levels. The heart pumping function must be below 41%, with increased troponin levels three times higher than normal. Heart-related symptoms should have started within 3 weeks before joining the study. For those aged 46 or older, a coronary angiogram must rule out coronary artery disease unless inflammation is confirmed by tissue test. Participants must enroll within 120 hours of hospital admission.
Main exclusion criteria: Patients with severe cardiac inflammation cannot participate.
Focus of the trial: The study monitors participants over six months to observe significant events such as death, heart transplant, or need for advanced heart support devices. Various health indicators are tracked, including heart function and blood protein levels indicating heart stress. The research aims to determine if corticosteroid treatment reduces serious heart-related events compared to standard care.
Investigational drugs: Corticosteroid therapy is administered intravenously in high doses as pulse therapy to reduce heart inflammation. The medication suppresses the immune system and reduces inflammation through inhibition of inflammatory mediators, potentially improving patient outcomes.
Study on the Effect of Cannabidiol (CardiolRx) on Heart Recovery in Patients with Acute Myocarditis
This trial investigates CardiolRx, a solution containing Cannabidiol, to evaluate its effectiveness and safety in helping heart recovery in patients with acute inflammation. The study compares CardiolRx with placebo over a period of up to 12 weeks.
Main inclusion criteria: Men and women 18 years or older with diagnosed acute inflammation confirmed through clinical symptoms (chest pain, irregular heartbeat, or shortness of breath with elevated troponin), cardiac magnetic resonance imaging within 10 days before enrollment, or heart tissue biopsy showing inflammation. Men with partners who can have children must use two forms of birth control, and women of childbearing age must use acceptable contraception for at least 2 months after finishing the study.
Main exclusion criteria: Patients with allergic reactions to the study medication, severe liver or kidney disease, pregnancy or breastfeeding, participation in another trial within 30 days, uncontrolled high blood pressure, active infections, cancer not in remission, other heart conditions that could interfere with the study, or inability to follow study procedures are excluded.
Focus of the trial: Participants take the oral treatment for up to 12 weeks while heart health is monitored using cardiac magnetic resonance imaging. The study measures changes in heart structure and function using specialized imaging techniques to determine the impact on heart recovery.
Investigational drugs: CardiolRx is administered orally in capsule form and is believed to work by reducing inflammation and oxidative stress in heart tissue. It is being studied as an anti-inflammatory agent to aid in heart muscle healing and improved function.
Summary
Current research into treatments for inflammation of the heart muscle spans multiple European countries, with France leading in the number of ongoing trials. The studies investigate various therapeutic approaches, including corticosteroids, anti-inflammatory medications, immune-modulating therapies, and novel compounds like Cannabidiol.
Several trials focus on corticosteroid therapy, particularly methylprednisolone, examining its effectiveness in different severity levels of the condition—from mild to fulminant cases. This concentration suggests strong research interest in understanding the optimal use of immune-suppressing medications for heart inflammation.
The research encompasses different patient populations, including both adults and children, with specific trials targeting pediatric intensive care patients. Treatment durations vary from short-term interventions of a few weeks to longer monitoring periods extending up to two years, reflecting the diverse nature of the condition and different treatment strategies being explored.
Most trials use advanced cardiac imaging techniques, particularly cardiac magnetic resonance imaging, to monitor treatment effectiveness and track changes in heart function over time. This standardized approach allows researchers to objectively measure improvements in heart muscle inflammation and pumping ability.
