Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Patients After Bone Marrow Transplantation

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Left Atrial and Left Ventricular Performance, as Assessed With 3D Echocardiography, in Patients After Bone Marrow Transplantation.

Conditions
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Hematopoietic Stem Cell Transplantation, Cardiotoxicity

Intervention / Treatment
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* Drug: ACE inhibitor, Sacubitril-Valsartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ACE group<br>patients after bone marrow transplantation will be treated with ACE inhibitor | Drug: ACE inhibitor, Sacubitril-Valsartan<br>* Search for Protective effect after chemotherapy and bone marrow transplantation<br>* Other names: Sacubitril-Valsartan;|
| Other: Sacubitril Valsartan group<br>patients after bone marrow transplantation will be treated with sacubitril valsartan | Drug: ACE inhibitor, Sacubitril-Valsartan<br>* Search for Protective effect after chemotherapy and bone marrow transplantation<br>* Other names: Sacubitril-Valsartan;|
| Other: Control group<br>patients after bone marrow transplantation will be treated neither with ACE i nor with sacubitril valsartan | Drug: ACE inhibitor, Sacubitril-Valsartan<br>* Search for Protective effect after chemotherapy and bone marrow transplantation<br>* Other names: Sacubitril-Valsartan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of treatment in Left Ventricular Function | Left Ventricular Function is assessed by calculating Ejection fraction by 3D echocardiography. | 2 years | 
| Effect of treatment in left ventricular function | Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography | 2 years | 
| Effect of treatment in arterial stiffness | Arterial Stiffness is evaluated by Pulse Wave Velocity | 2 years | 
| Effect of treatment in glycocalyx thickness | Glycocalyx thickness is assessed by measuring perfused boundary region (PBR) of the sublingual arterial microvessels (range 5-25 µm | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardio-oncology