Heart Failure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGBMAC
retrograde administration on non-selected BMAC via coronary sinus
Sponsors
University Hospital Ostrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with chronic heart failure and left ventricular ejection fraction ≤ 40% with coronary artery disease and with symptoms of heart failure in the NYHA class ≥ 3 on standard heart failure therapy for 3 months and in a stabilised state for at least 1 month * Age ≥18 years * Informed, written consent by the patient * Ability to comply fully with the study protocol * Negative pregnancy test (and effective contraception) in women with childbearing potential
Exclusion criteria
* Previous bone marrow disease (especially myelodysplastic syndrome or non-Hodgkin's lymphoma) * Acute myocardial infarction ˂ 1 week * Active infection or antibiotics treatment ˂ 1 week * Previous malingant ventricular arrhythmias without cardioverter-defibrilator (ICD) implantation * Anemia (HTC≤28%), leukocythosis (≥ 14.000/mm3) or thrombocytopenia (≤50.000/mm3) * Previous bleeding diathesis * Need for hematopoietic growth factor treatment (e.g. erythropoetin, G-CSF) * Impossibility of aspiration 240ml of bone marrow * Hepathopathy or cirrhosis (bilirubin, ALT or AST ≥ 2,5x upper limit of normal) * Terminal renal insufficiency or haemodyalysis * Uncontrolled hypertension * Need for high dose (\> 7.5mg/day) corticotherapy within the next 6 months * Inability to stop anticoagulation therapy (\>72 hours) before bone marrow aspiration * Known malignancies requiring actino or chemotherapy, or previous actinotherapy * Patients with a BMI \>40 * Known allergy to contrast agents * Other comorbidities with a life expectancy of 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular end-systolic volume (LVESV) | 12 month | Left ventricular end-systolic volume |
| Left ventricular end-diastolic volume (LVEDV) | 12 month | Left ventricular end-diastolic volume |
| ejection fraction of left ventricle (EF LV) | 12 month | ejection fraction of left ventricle |
| Left ventricular end-systolic diameter (LVESd) | 12 month | Left ventricular end-systolic diameter |
| Left ventricular end-diastolic diameter (LVEDd) | 12 month | Left ventricular end-diastolic diameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QoL | 12 month | Quality of patients´ life using the Minnesota questionnaire |
| corridor walk test | 12 month | walk distance in 6 min corridor walk test |
Countries
Czechia
Outcome results
None listed