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临床试验/NCT04964531
NCT04964531Unknown不适用

Left Ventricular Remodeling After Transcatheter Closure of the Patent Ductus Arteriosus. Comparative Study Between Different Age Groups

Ahmed Mohamed Moheb El-Din0 个研究点目标入组 48 人开始时间: 2021年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
48
主要终点
change of LV strain after transcatheter closure of the PDA

研究概览

简要总结

failure of closure of the ductus arteriosus after birth results in a congenital anomaly known as patent ductus arteriosus. The large ductus can induce left side heart remodeling changes which could interfere with the normal cardiac function.

详细描述

Patent ductus arteriosus (PDA) is a congenital heart disease that represents 6-11% of all congenital heart diseases and is due to failure of spontaneous closure of a normal foetal duct called ductus arteriosus, that is a duct connecting the left pulmonary artery to the aorta, and it may result in LV volume overload , pulmonary overflow that may end with development of Eisenmenger syndrome. LV volume overload of the big ductus induce left heart remodeling changes in form of LA and LV dilatation, and LV hypertrophy to compensate for the increased wall stress. Some patients compensate well and remain asymptomatic, while others can't and develop manifestations of LV systolic dysfunction .

Traditional echocardiography is the main diagnostic tool for the PDA and assessment of its hemodynamic effect on the heart. speckle tracking echocardiography ( STE) is a relatively novel tool that can assess the LV function by tracking the speckles of the grey scale 2D images. Recent studies revealed good correlation between the LVEF measured by traditional echocardiography and global longitudinal strain (GLS) measured by STE , in addition to detection of subtle myocardial dysfunction by STE in patients with heart failure with preserved LVEF before frank LV systolic dysfunction is apparent clinically .

PDA closure should induce reverse remodelling with improvement of the left heart dimensions and function . Many studies in pediatrics showed deterioration of LVEF early after PDA closure followed by rapid recovery , while fewer studies showed late improvement of the LVEF in the adults .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • all patients who are candidate for transcatheter PDA closure.

排除标准

  • Patients with PDA dependent pulmonary circulation.
  • Patients with small sized PDA which is silent by auscultation.
  • Patients with large sized PDA which is unsuitable for Trans-catheter closure .
  • Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).
  • Patients with active infection or active infective endarteritis.
  • Patients refusing the study.
  • Patients with DM, HTN and ischemic heart diseases.
  • Patients with associated congenital or acquired cardiac lesions that may interfere with LV mechanics.

结局指标

主要结局

change of LV strain after transcatheter closure of the PDA

时间窗: at base line, within 48 hours after closure of the duct then at three and six months

Assess the change of left ventricular longitudinal and circumferential strain by speckle tracking echocardiography after PDA closure, and compare this change between the children and adults.

次要结局

未报告次要终点

研究者

发起方
Ahmed Mohamed Moheb El-Din
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Mohamed Moheb El-Din

Assistant lecturer

Assiut University

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