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

National and Kapodistrian University of Athens

Status: Unknown

Conditions: Cardiotoxicity; Hematopoietic Stem Cell Transplantation

Treatments: Drug: ACE inhibitor, Sacubitril-Valsartan

Study type: Interventional

Funder types: Other

Identifiers

NCT04092309

ACE_SAVA_3Decho_BMT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

ACE group

Other group

Description:

patients after bone marrow transplantation will be treated with ACE inhibitor

Treatment:

Drug: ACE inhibitor, Sacubitril-Valsartan

Sacubitril Valsartan group

Other group

Description:

patients after bone marrow transplantation will be treated with sacubitril valsartan

Treatment:

Drug: ACE inhibitor, Sacubitril-Valsartan

Control group

Other group

Description:

patients after bone marrow transplantation will be treated neither with ACE i nor with sacubitril valsartan

Treatment:

Drug: ACE inhibitor, Sacubitril-Valsartan