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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone marrow autologous cells concentrate (BMAC) | Experimental | retrograde administration on non-selected BMAC via coronary sinus |
|
| Control | Placebo Comparator | standard treatment o heart failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMAC | Drug | retrograde administration on non-selected BMAC via coronary sinus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular end-systolic diameter (LVESd) | Left ventricular end-systolic diameter | 12 month |
| Left ventricular end-systolic volume (LVESV) | Left ventricular end-systolic volume | 12 month |
| Left ventricular end-diastolic diameter (LVEDd) | Left ventricular end-diastolic diameter | 12 month |
| Left ventricular end-diastolic volume (LVEDV) | Left ventricular end-diastolic volume | 12 month |
| ejection fraction of left ventricle (EF LV) | ejection fraction of left ventricle | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| corridor walk test | walk distance in 6 min corridor walk test | 12 month |
| QoL | Quality of patients´ life using the Minnesota questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leoš Pleva, MD,PhD | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Ostrava-Poruba | Moravian-Silesian Region | 708 52 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30704414 | Derived | Pleva L, Kukla P, Vitkova K, Prochazka V. Rationale and design of a prospective, randomised study of retrograde application of bone marrow aspirate concentrate (BMAC) through coronary sinus in patients with congestive heart failure of ischemic etiology (the RETRO study). BMC Cardiovasc Disord. 2019 Jan 31;19(1):32. doi: 10.1186/s12872-019-1011-9. |
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There exists no plan to make individual participant data available to other researchers. The data may be provided upon request.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 12 month |