RANDOMIZED, MULTICENTRIC STUDY COMPARING THE EFFECT OF TWO REGIMENS OF COMBINED IMMUNOSUPPRESIVE THERAPY IN THE TREATMENT OF INFLAMMATORY CARDIOMYOPATHY CZECH-ICIT (CZECH INFLAMMATORY CARDIOMYOPATHY IMMUNOSUPPRESSION TRIAL) - CZECH-ICIT

Fakultní nemocnice u sv. Anny v Brne0 sites234 target enrollmentSeptember 14, 2012

ConditionsPatients with endomyocardial biopsy (EMB) proven inflammatory cardiomyopathy (ICM) defined by EMB established presence of myocardial inflammation and absence of cardiotropic infectious agents established by PCR.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

DrugsPrednison 5 léciva Imuran 25 mg Imuran 50mg Prednison 20 Léciva

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with endomyocardial biopsy (EMB) proven inflammatory cardiomyopathy (ICM) defined by EMB established presence of myocardial inflammation and absence of cardiotropic infectious agents established by PCR.
Sponsor: Fakultní nemocnice u sv. Anny v Brne
Enrollment: 234
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 14, 2012

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Fakultní nemocnice u sv. Anny v Brne

Eligibility Criteria

Inclusion Criteria

•1\.Males and females aged 18 to 65 years at the time of signing the informed consent
•2\.Signing of the informed consent.
•3\. LV systolic dysfunction defined by ejection fraction less than or equal 40% as assessed by echocardiography and symptoms of heart failure (minimum NYHA class II) lasting for at least 2 weeks at the time of randomization. This criterion also determines the inclusion of the study subjects in one of two substudies (CZECH\-ICIT 1 or CZECH\-ICIT 2\).
•\-LV systolic dysfunction (defined by ejection fraction less than or equal 40%) and symptoms of heart failure (minimun NYHA class II) lasting 2 weeks to 6 months, with standard medical therapy of chronic heart failure given for at least 2 weeks – the subject fullfills criterion for inclusion in CZECH\-ICIT 1 substudy
•\-LV systolic dysfunction (defined by ejection fraction less than or equal 40%) and symptoms of heart failure (minimum NYHA class II) lasting more than 6 months, with standard medical therapy of chronic heart failure given for at least 2 weeks – the subject fullfills criterion for inclusion in CZECH\-ICIT 2 substudy
•4\.Positive imunohistochemistry finding of myocardial inflammation in endomycardial biopsy (EMB). EMB must have been be performed no more than 6 weeks prior to the inclusion in the study. Positive imunohistochemistry EMB finding demonstrating myocardial inflammation is defined by the presence of at least 7/mm2 CD\-3 positive lymphocytes and/or at least 14 infiltrating leucocytes (LCA\+ cells)/mm2 in the specimen.
•5\.The absence of infectious agent in EMB is defined by negative results of PCR testing of EMB specimens. PCR testing will be aimed to exclude the presence of enteroviruses (ECHO, coxsackie), adenoviruses, herpes viruses (HSV\-1, EBV, CMV, HHV\-6\), Borrelia burgdorferi and parvorvirus B19\. In the case of parvovirus B19, a negative PCR result will be considered when less than 500 viral copies/ug genomic DNA are detected. EMB must have been performed no more than 6 weeks prior to the inclusion in the study.
•6\.Negative blood pregnancy test in fertile females.
•7\. Effective form of contraception in fertile females (hormonal contraception and/or 2 barrier contraception)
•Are the trial subjects under 18? no

Exclusion Criteria

•1\.The presence of coronary artery disease, defined by angiographic findings of one or more coronary artery stenosis \> 50%, history of previous myocardial infarction and/or percutaneous or surgical myocardial revascularization. Coronary angiography must not have been performed more than 2 years before randomization into the study.
•2\.Permanent pacemaker including cardiac resynchronization therapy.
•3\.The presence of uncontrolled, persistent supraventricular tachyarrhythmia, with ventricular rate \> 120/min, lasting more than 1 week before EMB.
•4\.The presence of uncontrolled arterial hypertension, defined by blood pressure values \> 180mmHg (for systolic) and/or \> 110mmHg (for diastolic) lasting more than 3 months.
•5\.The presence of at least moderately hemodynamically significant primary valvulopathy or congenital heart disease (apart from patent foramen ovale and non\-significant atrial septal defect).
•6\.Previous heart valve surgery (replacement or reconstruction) or surgical correction of congenital heart disease.
•7\.A history of cytostatic therapy or radiotherapy.
•8\.Alcoholism defined as ethanol intake \>90 g/day.
•9\.The presence of uncontrolled endocrine of metabolic disorder.
•10\.Gravidity and lactation.