Micophenolate Mofetil Versus Azathioprine in Myocarditis (NCT05237323) | Clinical Trial Compass
CompletedPhase 3
Micophenolate Mofetil Versus Azathioprine in Myocarditis
Russia50 participantsStarted 2020-10-01
Plain-language summary
The study is aimed at studying the direct efficacy of mycophenolate mofetil (mycophenolate mofetil, CellCept, Genentech, N015393/02, 12.08.2009) (in combination with corticosteroids (methylprednisolone, Metypred, Orion, 003467, 26.02.2016)) in the treatment of lymphocytic myocarditis: the effect on symptoms, structural and functional parameters of the heart, on the outcomes of lymphocytic myocarditis: mortality, the need for transplantation, other surgical interventions, the incidence of unwanted side effects, and forced cancellation (replacement) of the drug. To compare the data on the efficacy and safety of therapy with mycophenolate mofetil (in combination with corticosteroids) with the standard regimen of therapy for lymphocytic myocarditis (corticosteroids in combination with azathioprine), including in cases of forced replacement of drugs with each other.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Presence of written informed consent of the patient to participate in the study;
* Age 18 and older;
* The diagnosis of myocarditis, established using endomyocardial biopsy (active or borderline myocarditis according to Dallas criteria, virus negative, excluding parvovirus B19);
* Chronic heart failure 2-4 according to New York Heart Association functional classification;
* Signs of left ventricular dysfunction, persisting after 2 months of optimal drug therapy (therapy for heart failure, including angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, beta-blockers, mineralocorticoid receptor antagonists, diuretics, angiotensin receptors and neprilysin inhibitors): end-diastolic the size of the left ventricle is more than 5.5 cm, the ejection fraction is less than 50%;
Non-inclusion criteria:
* History of myocardial infarction/acute coronary syndrome.
* Chronic ischemic heart disease with hemodynamically significant stenoses of the coronary arteries (70% or more).
* Congenital heart defects.
* History of infective endocarditis less than 6 months old.
* Thyrotoxic heart.
* Hypertensive heart (left ventricular hypertrophy more than 14 mm).
* Hypertrophic cardiomyopathy.
* Verified amyloidosis, sarcoidosis, other storage diseases.
* Diffuse connective tissue diseases.
* Verified systemic vasculitis.
* Lymphoproliferative diseases.
* Condition after chemotherapy with anthracycline drugs.
* Heart surgery less than 2 months old.
Exc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
cardiovascular death
Timeframe: From the start of therapy for at least one year or until the patient's death
2
heart transplant
Timeframe: From the start of therapy for at least one year or until the patient's death
Trial details
NCT IDNCT05237323
SponsorI.M. Sechenov First Moscow State Medical University