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Micophenolate Mofetil Versus Azathioprine in Myocarditis

NCT05237323 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

mycophenolate mofetil 2 g per day

mycophenolate mofetil 2 g per day and methylprednisolone in an average starting dose 24 \[24; 32\] mg per day and standard drug therapy for heart failure.

DRUG

azathioprine of 150 [75; 150] mg per day

azathioprine at an average dose of 150 \[75; 150\] mg per day and methylprednisolone in an average starting dose 24 \[24; 32\] mg per day and standard drug therapy for heart failure.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Ruslan S Rud' · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2025-07-10
Completion
2025-07-10

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05237323 on ClinicalTrials.gov