Status:
COMPLETED
Micophenolate Mofetil Versus Azathioprine in Myocarditis
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Lymphocytic Myocarditis (Disorder)
Heart Failure
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 (methylprednisolon...
Detailed Description
From October 2020 to December 2022, it is planned to enroll 50 patients in "case-control" study diagnosed with virus negative lymphocytic myocarditis at the University Clinical Hospital No. 1, who mee...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05237323
Start Date
October 1 2020
End Date
July 10 2025
Last Update
July 15 2025
Active Locations (1)
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1
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Bol'shaya Pirogovskaya Street 6, 1 Building ,, Russia, 119435