Micophenolate Mofetil Versus Azathioprine in Myocarditis

NCT05237323 | Completed Phase 3 DMC

• 1 other identifier: 122
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 (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

Lymphocytic Myocarditis (Disorder); Heart Failure; Dilated Cardiomyopathy; Cardiomyopathies; Sudden Cardiac Death

Keywords

virus-negative lymphocytic myocarditis; myocarditis; immunosuppressive therapy; azathioprine; glucocorticosteroids; endomyocardial biopsy; Parvovirus B19; Anticardial antibodies

Outcome Measures

Primary Outcomes (2)

• cardiovascular death

  frequency of biological death from cardiovascular causes of a patient recorded in a hospital or at home, confirmed by a death certificate (with or without autopsy results); the relevant information was obtained directly from the relatives of the deceased.

  From the start of therapy for at least one year or until the patient's death

• heart transplant

  frequency of heart transplantation due to lack of effect from immunosuppressive therapy and standard cardiotropic therapy with persistent heart failure of NYHA functional class 4 requiring constant inotropic or circulatory support or Intractable life-threatening arrhythmias unresponsive to medical therapy, catheter ablation, surgery, and/or implantable cardioverter-defibrillator.

  From the start of therapy for at least one year or until the patient's death

Secondary Outcomes (22)

• Dynamics of heart failure in accordance with New York Heart Association classification

  up to 1 week, 2 months after therapy, then 6 months later

• dynamics of left ventricle ejection fraction

  up to 1 week

• dynamics of left ventricle ejection fraction

  2 months after starting therapy

• dynamics of left ventricle ejection fraction

  6 months after starting therapy

• dynamics of the end-diastolic diameter of the left ventricle (cm)

  up to 1 week

Study Arms (2)

main group

EXPERIMENTAL

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)).

Drug: mycophenolate mofetil 2 g per day

control group

ACTIVE COMPARATOR

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))

Drug: azathioprine of 150 [75; 150] mg per day

Interventions

mycophenolate mofetil 2 g per day DRUG

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.

main group

azathioprine of 150 [75; 150] mg per day DRUG

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.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%;
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Bol'shaya Pirogovskaya Street 6, 1 Building ,, 119435, Russia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Heart Failure; Cardiomyopathy, Dilated; Cardiomyopathies; Death, Sudden, Cardiac; Myocarditis

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Ruslan S Rud'

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 14, 2022
• Study Start: October 1, 2020
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)