Micophenolate Mofetil Versus Azathioprine in Myocarditis
Lymphocytic Myocarditis (Disorder), Heart Failure, Dilated Cardiomyopathy
About this trial
This is an interventional treatment trial for Lymphocytic Myocarditis (Disorder) focused on measuring virus-negative lymphocytic myocarditis, myocarditis, immunosuppressive therapy, azathioprine, glucocorticosteroids, endomyocardial biopsy, Parvovirus B19, Anticardial antibodies
Eligibility 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)
Sites / Locations
- I.M. Sechenov First Moscow State Medical University (Sechenov University)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
main group
control group
Group 1 included 25 patients who received mycophenolate mofetil 2 g per day per os and methylprednisolone in an average starting dose 24 [24; 32] mg per day per os and standard drug therapy for heart failure (beta-blockers, angiotensin converting enzyme inhibitors or angiotensin II receptor blocker, mineralocorticoid receptor antagonist angiotensin receptor-neprilysin inhibitor (if required), diuretics (if required)).
Group 2 included 25 patients who received azathioprine at an average dose of 150 [75; 150] mg per day per os and methylprednisolone in an average starting dose 24 [24; 32] mg per day per os and standard drug therapy for heart failure (beta-blockers, angiotensin converting enzyme inhibitors or angiotensin II receptor blocker, mineralocorticoid receptor antagonist angiotensin receptor-neprilysin inhibitor (if required), diuretics (if required))