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Study on the Effects of Mycophenolate Mofetil and Prednisolone in Patients with Chronic Virus-Negative Inflammatory Cardiomyopathy

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a heart condition known as virus-negative inflammatory cardiomyopathy. This condition affects the heart muscle, leading to a decrease in the heart's ability to pump blood effectively. The study aims to evaluate the effects of an immunosuppressive treatment using two medications: mycophenolate mofetil (also known as Mowel) and prednisolone. These medications are being compared to a placebo to determine their effectiveness in improving heart function.

The purpose of the study is to assess whether the treatment can lead to an improvement in heart function over a period of 12 months. Participants in the study will receive either the active medications or a placebo, and their heart function will be monitored using MRI scans. The study will track changes in heart function and other health outcomes over time to see if the treatment provides any benefits.

Participants will be randomly assigned to receive either the active treatment or a placebo, and neither the participants nor the researchers will know which treatment is being given. This is known as a double-blind study. The trial will last for up to 12 months, during which participants will have regular check-ups and tests to monitor their heart health and overall well-being. The results of this study could help improve treatment options for people with this type of heart condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and initial assessment
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the actual medication, and the other will receive a placebo, which looks like the medication but does not contain the active ingredients.
An initial assessment will be conducted to evaluate your heart function and overall health. This may include tests such as an MRI and echocardiogram to measure your heart's performance.
Step 2
Medication administration
If you are in the treatment group, you will receive two medications: prednisolone and mycophenolate mofetil. Prednisolone will be given in tablet form, with dosages of 1 mg, 5 mg, 10 mg, or 20 mg, taken orally. Mycophenolate mofetil will be provided as 500 mg film-coated tablets, also taken orally.
The exact dosage and frequency will be determined by the study team, and you will be required to take the medication as instructed for the duration of the trial.
Step 3
Follow-up assessments
Throughout the trial, regular follow-up assessments will be conducted to monitor your heart function and overall health. These assessments will occur at 6 months and 12 months after starting the trial.
Tests may include MRI and echocardiogram to measure changes in your heart's performance, as well as other evaluations to assess your exercise capacity and quality of life.
Step 4
Completion of trial
At the end of the 12-month period, a final assessment will be conducted to evaluate the effects of the treatment on your heart function.
The results will be analyzed to determine the effectiveness of the medication compared to the placebo.

Who can join the trial?

7 criteria

Must be at least 18 years old.
Must have been receiving medical treatment for heart failure for at least 3 months but not longer than 10 years, following current guidelines.
Must have a left ventricular ejection fraction (LVEF) of less than 50% as shown by an echocardiogram (a heart ultrasound) taken within the last month. LVEF is a measure of how well the heart is pumping blood.
Must have a heart biopsy showing signs of lymphocytic myocarditis, which is a type of heart inflammation. This includes having at least 14 white blood cells per square millimeter, with up to 4 being a type called monocytes, and at least 7 being a type called CD3 positive T-lymphocytes. There should also be increased expression of a protein called MHC-II.
Must not have any established infection with certain viruses in the heart biopsy, such as enteroviruses, HHV-6, EBV, CMV, adenoviruses, or parvovirus B19 with more than 500 copies.
If a woman can have children, she must have a negative pregnancy test and use a highly effective method of birth control.
Must provide written informed consent, which means agreeing to participate in the study after understanding all the details and risks.

Who cannot join the trial?

10 criteria

Patients who have not been diagnosed with virus-negative inflammatory dilated or nondilated left ventricular cardiomyopathy. This means the heart muscle is not inflamed due to a virus and is either enlarged or not enlarged.
Patients whose heart function has not worsened despite receiving the best possible treatment for heart failure.
Patients who are not within the specified age range for the study.
Patients who are not willing or able to follow the study procedures.
Patients who are pregnant or breastfeeding.
Patients with other medical conditions that might interfere with the study.
Patients who are participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who have had a recent major surgery.
Patients who have a known allergy to the study medications.

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Verified sites

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

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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
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Goethe University Frankfurt
Frankfurt, Germany
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Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, Germany

Trial locations

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Investigated drugs

Mycophenolate mofetil (MMF)
is a medication used to suppress the immune system. In this trial, it is being tested to see if it can help improve heart function in patients with a specific type of heart disease that is not caused by a virus. By reducing the activity of the immune system, MMF may help decrease inflammation in the heart, potentially leading to better heart performance.
Prednisolone
is a type of steroid that is also used to suppress the immune system and reduce inflammation. In this trial, it is being used alongside MMF to see if the combination can improve heart function in patients with the specified heart condition. Prednisolone works by decreasing the body's immune response, which may help reduce inflammation in the heart and improve its function over time.

What is already known about the treatment

Mycophenolate mofetil (MMF)
This medication is administered orally and is used in the TRINITY trial to treat patients with a specific type of heart condition called virus-negative inflammatory cardiomyopathy. It is currently being studied to see if it can improve heart function in these patients. MMF works by suppressing the immune system to reduce inflammation in the heart. It is classified as an immunosuppressant.
Prednisolone
This medication is also administered orally and is part of the TRINITY trial for treating virus-negative inflammatory cardiomyopathy. It is being evaluated for its potential to improve heart function in affected patients. Prednisolone works by reducing inflammation and suppressing the immune system. It is classified as a corticosteroid.

Investigated diseases

Inflammatory Dilated Cardiomyopathy – This condition involves inflammation of the heart muscle, leading to an enlarged and weakened heart. It affects the heart's ability to pump blood efficiently, causing symptoms like fatigue, shortness of breath, and swelling in the legs. Over time, the heart's chambers may become dilated, further reducing its pumping efficiency. The disease can progress to heart failure if the heart becomes too weak to meet the body's needs. In some cases, the inflammation may subside, but the structural changes to the heart can remain. The progression can vary, with some individuals experiencing a gradual worsening of symptoms.