Cardiotoxicity, Hematopoietic Stem Cell Transplantation
Conditions
Keywords
Cardio-oncology
Brief summary
The purpose of the present study is to investigate the effect of ACE inhibitors and the sacubitril-valsartan complex in bone marrow transplant patients by assessing cardiovascular and endothelial parameters in order to search for a potent protective role.
Detailed description
The purpose of the present study is to investigate the effect of ACE inhibitors and the sacubitril-valsartan complex in bone marrow transplant patients in preventing cardiotoxicity when administered immediately after transplantation. The effect of medication will be studied in detail: i) in global longitudinal strain of left ventricle (GLS), ii) in the volume change of the right and the left ventricle, through the cardiac cycle using 3D echocardiography, iii) in the Myocardial Work Index (MWI) of the left ventricle, with a strain -pressure curve study iv) in the 4D strain of the left atrium, v) in elastic properties of aorta (pulse wave velocity (PWV), central systolic pressure (CSBP-mmHg) and augmentation index (Aix%), vii) in permeability of glycocalyx and viii) in serum biomarker values, namely troponin I high sensitivity and atrial natriuretic peptide (NT-proBNP).
Interventions
DRUGACE inhibitor, Sacubitril-Valsartan
Search for Protective effect after chemotherapy and bone marrow transplantation
Sponsors
University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
one group after bone marrow transpalntation treated with ACE one group after bone marrow transpalntation treated with sacubitril-valsartan one group after bone marrow transpalntation treated with none of these (control group)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adolescents male and female * that have just been treated with bone marrow transplantation due to haematological malignancies.
Exclusion criteria
* Coronary Artery Disease * Permanent Atrial Fibrilation * Signs of Left Ventricular Hypertrophy on electrocardiography or echocardiography * Left ventricle Ejection Fraction\<50% or segmental wall motion abnormalities of left ventricle * More than moderate valvular disease * Primary Myocardiopathy * Blood Pressure\<90 mmHg * GFR\<30 ml/min/1,73m2 * Unwilling to recruit * Uncontrolled Arterial hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of treatment in arterial stiffness | 2 years | Arterial Stiffness is evaluated by Pulse Wave Velocity |
| Effect of treatment in glycocalyx thickness | 2 years | Glycocalyx thickness is assessed by measuring perfused boundary region (PBR) of the sublingual arterial microvessels (range 5-25 µm |
| Effect of treatment in Left Ventricular Function | 2 years | Left Ventricular Function is assessed by calculating Ejection fraction by 3D echocardiography. |
| Effect of treatment in left ventricular function | 2 years | Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography |
Countries
Greece
Contacts
Primary ContactIgnatios Ikonomidis, Assoc.Prof.
Backup ContactKonstantinos Katogiannis, Fellow
Outcome results
None listed