NCT05237323CompletedPhase 3
Micophenolate Mofetil Versus Azathioprine in Myocarditis
The Efficacy and Safety of Mycophenolate Mofetil in the Treatment of Lymphocytic Myocarditis in Comparison With Azathioprine
Source: ClinicalTrials.gov · Last updated 15 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 13 Jan 2022
- Start date
- 1 Oct 2020
- Primary completion date
- 10 Jul 2025
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Diseases
- Heart failure
- NCT number
- NCT05237323
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 50
- From 1 Oct 2020 to the primary completion date, 10 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inability to adequately control therapy and follow the research protocol (serious mental disorders, remoteness of residence, non-compliance of the patient)
Other
- Patient refusal to participate in the study;
- Pregnancy;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| I.M. Sechenov First Moscow State Medical University (Sechenov University) Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.