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

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04092309
• Other study ID #: ACE_SAVA_3Decho_BMT
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: April 2020
• Source: University of Athens
• Contact: Ignatios Ikonomidis, Assoc.Prof.
• Phone: +30 2105832192
• Email: ignoik[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiotoxicity
• Hematopoietic Stem Cell Transplantation

Intervention

Drug:
• ACE inhibitor, Sacubitril-Valsartan
Search for Protective effect after chemotherapy and bone marrow transplantation

Locations

Country	Name	City	State
Greece	"Attikon" University General Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of treatment in Left Ventricular Function	Left Ventricular Function is assessed by calculating Ejection fraction by 3D echocardiography.	2 years
Primary	Effect of treatment in left ventricular function	Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography	2 years
Primary	Effect of treatment in arterial stiffness	Arterial Stiffness is evaluated by Pulse Wave Velocity	2 years
Primary	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