Clinical trial NCT04092309: Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Patients After Bone Marrow Transplantation
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Cardiotoxicity
Keywords: Cardio-oncology
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Effect of treatment in Left Ventricular Function
timeFrame: 2 years
measure: Effect of treatment in left ventricular function
timeFrame: 2 years
measure: Effect of treatment in arterial stiffness
timeFrame: 2 years
measure: Effect of treatment in glycocalyx thickness
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Attikon" University General Hospital
state: Attiki
Study officials:
affiliation: Athens University
name: Ignatios Ikonomidis, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References: