The aim of our prospective randomised study is to assess the efficacy of the retrograde application of non-selected bone marrow autologous cells concentrate (BMAC) in patients with heart failure with reduced ejection fraction of left ventricle (HFREF) of ischemic aetiology. The evaluated preparation is concentrated BMAC, obtained using Harvest SmartPReP2 technology.
Our assumption is that non-selected BMAC administrations will lead to improvements in the left ventricular ejection fraction (LV EF), the left ventricular end-systolic and end-diastolic diameters and volumes (measured with magnetic resonance imaging) compared to standard heart failure therapy. Furthermore, it will be associated with improved exercise tolerance in the six-minute corridor walk test and an improvement in the life quality of patients without increasing the incidence of severe ventricular arrythmias.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
retrograde administration on non-selected BMAC via coronary sinus
University Hospital Ostrava
Ostrava-Poruba, Moravian-Silesian Region, Czechia
Left ventricular end-systolic diameter (LVESd)
Left ventricular end-systolic diameter
Time frame: 12 month
Left ventricular end-systolic volume (LVESV)
Left ventricular end-systolic volume
Time frame: 12 month
Left ventricular end-diastolic diameter (LVEDd)
Left ventricular end-diastolic diameter
Time frame: 12 month
Left ventricular end-diastolic volume (LVEDV)
Left ventricular end-diastolic volume
Time frame: 12 month
ejection fraction of left ventricle (EF LV)
ejection fraction of left ventricle
Time frame: 12 month
corridor walk test
walk distance in 6 min corridor walk test
Time frame: 12 month
QoL
Quality of patients´ life using the Minnesota questionnaire
Time frame: 12 month
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