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

Not Applicable

• Conditions: Hematopoietic Stem Cell Transplantation; Cardiotoxicity
• Interventions: Drug: ACE inhibitor, Sacubitril-Valsartan

• Registration Number: NCT04092309
• Lead Sponsor: University of Athens

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).

Study Timeline

• Study First Submitted: 2019-09-14
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-17
• Study Start: 2019-09-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03
• Primary Completion: 2020-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACE group	ACE inhibitor, Sacubitril-Valsartan	patients after bone marrow transplantation will be treated with ACE inhibitor
Sacubitril Valsartan group	ACE inhibitor, Sacubitril-Valsartan	patients after bone marrow transplantation will be treated with sacubitril valsartan
Control group	ACE inhibitor, Sacubitril-Valsartan	patients after bone marrow transplantation will be treated neither with ACE i nor with sacubitril valsartan

Primary Outcome Measures

Name	Time	Method
Effect of treatment in arterial stiffness	2 years	Arterial Stiffness is evaluated by Pulse Wave Velocity
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
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

Trial Locations

Locations (1)

"Attikon" University General Hospital; 🇬🇷 Athens, Attiki, Greece