The aim of this study is to compare the effect of combined immunosuppressive therapy given on the top standard medical therapy of chronic heart failure according to current guidelines with standard medical therapy of chronic heart failure alone in patients with infammatory cardiomyopathy (ICM). Suitable subjects are characterized by EMB established presence of myocardial inflammation / negative polymerase chain reaction assay (PCR) findings of cardiotropic infectious agents and with varying duration of heart failure symptoms and left ventricular (LV) systolic dysfunction (phase A). Further, to compare the effect of two regimens of combined immunosuppressive therapy in these patients with ICM (phase B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
234
* Prednisone for a total of 90 days, with initial dose 1mg/kg/day p.o., given for 12 days and then tapered every 5 days for 5mg/day to the maintenance dose of 0.2mg/kg/day. The daily dose of Prednisone will be rounded to the nearest value divisible by 5. * Azathioprine for 100 days in total, with dose 1 mg/kg/day. The daily dose of Azathioprine will be rounded to the nearest value divisible by 25.
* Prednisone for a total of 6 months, with initial dose 1mg/kg/day p.o. given for 4 weeks with a subsequent maintenance dose of 0,33 mg/kg/den. The daily dose of Prednisone will be rounded to the nearest value divisible by 5. * Azathioprine for 6 months in total, with dose 2mg/kg/day. The daily dose of Azathioprine will be rounded to the nearest value divisible by 25.
No intervention, only standard medical therapy
St. Anne's University Hospital Brno
Brno, Czechia
RECRUITINGGeneral University hospital in Prague
Prague, Czechia
RECRUITINGcomparison of the change in LV ejection fraction
Time frame: baseline and in 12 months after the initiation of immunosuppressive therapy
comparison of the change of LV end-diastolic and end-systolic diameters
Time frame: baseline and in 12 months after the initiation of immunosuppressive therapy
comparison of the change of New York Heart Association (NYHA) class
Time frame: baseline and in 12 months after the initiation of immunosuppressive therapy
comparison of total mortality
Time frame: baseline and in 12 months after the initiation of immunosuppressive therapy
comparison of the combined end-point
combined end-point (death from cardiac reasons, heart transplantation, hospitalization for heart failure, successful resuscitation for cardiac arrest and adequate implantable cardioverter-defibrillator (ICD) shock for ventricular tachycardia or fibrillation
Time frame: baseline and in 12 months after the initiation of immunosuppressive therapy
comparison of the change in the number of infiltrating inflammatory cells in EMB
Time frame: baseline and in 12 months after the initiation of immunosuppressive therapy
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