Micophenolate Mofetil Versus Azathioprine in Myocarditis

• Status: Recruiting
• Trial end date: 2023-05-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: I.M. Sechenov First Moscow State Medical University
• Treatments: Azathioprine; Mycophenolic Acid

Criteria

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.

Exclusion Criteria:

• Patient refusal to participate in the study;

• Pregnancy;

• Inability to adequately control therapy and follow the research protocol (serious mental disorders, remoteness of residence, non-compliance of the patient)