NCT01877746

CZECH-ICIT (CZECH Inflammatory Cardiomyopathy Immunosuppression Trial)

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: St. Anne's University Hospital Brno, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Inflammatory Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Combination of prednisone and azathioprine	* 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.
DRUG	Combination of prednisone and azathioprine	* 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.
OTHER	No intervention	No intervention, only standard medical therapy

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-06-14
• Last updated: 2013-06-14

Locations

2 sites across 1 country: Czechia