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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Effect of treatment in Left Ventricular Function
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents male and female
- •that have just been treated with bone marrow transplantation due to haematological malignancies.
排除标准
- •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
研究组 & 干预措施
ACE group
patients after bone marrow transplantation will be treated with ACE inhibitor
干预措施: ACE inhibitor, Sacubitril-Valsartan (Drug)
Sacubitril Valsartan group
patients after bone marrow transplantation will be treated with sacubitril valsartan
干预措施: ACE inhibitor, Sacubitril-Valsartan (Drug)
Control group
patients after bone marrow transplantation will be treated neither with ACE i nor with sacubitril valsartan
干预措施: ACE inhibitor, Sacubitril-Valsartan (Drug)
结局指标
主要结局
Effect of treatment in Left Ventricular Function
时间窗: 2 years
Left Ventricular Function is assessed by calculating Ejection fraction by 3D echocardiography.
Effect of treatment in left ventricular function
时间窗: 2 years
Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography
Effect of treatment in arterial stiffness
时间窗: 2 years
Arterial Stiffness is evaluated by Pulse Wave Velocity
Effect of treatment in glycocalyx thickness
时间窗: 2 years
Glycocalyx thickness is assessed by measuring perfused boundary region (PBR) of the sublingual arterial microvessels (range 5-25 µm
次要结局
未报告次要终点
研究者
Ignatios Ikonomidis
Principal Investigator
University of Athens