Micophenolate Mofetil Versus Azathioprine in Myocarditis
Status:
Recruiting
Trial end date:
2023-05-29
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University