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临床试验/NCT07568002
NCT07568002尚未招募不适用

Impact of Transcatheter Patent Ductus Arteriosus Closure on Left Atrial and Ventricular Remodeling in Adults and Adolescents.

Emil Magdy Badry0 个研究点目标入组 40 人开始时间: 2026年6月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40

研究概览

简要总结

During the fetal life, small portion of the RV output passes to the lung through the pulmonary artery, while the greater portion is shunted to the descending aorta through the fetal ductus arteriosus (1) which is a connection between the left pulmonary artery and descending thoracic aorta just distal to the left subclavian artery.

With transition from intrauterine to extrauterine life, physiological changes occur resulting in left to right reversal of the shunt through the ductus arteriosus. Increased oxygenation after birth results in calcium and potassium channel activity ending in ductus closure(2).

Patent ductus arteriosus (PDA ) is a congenital heart disease(CHD) represents 6-11% of all CHDs (3) and results from failure of closure of the ductus beyond the third month of age(4).

However, there are a subset of patients who survive to adulthood undiagnosed, and it is present in adulthood with various clinical presentations. The clinical presentation, hemodynamics, and management of PDA presentation in adults depend on various factors, primarily the size of PDA, magnitude of shunting, and status of pulmonary vasculature (5).

详细描述

During the fetal life, small portion of the RV output passes to the lung through the pulmonary artery, while the greater portion is shunted to the descending aorta through the fetal ductus arteriosus (1) which is a connection between the left pulmonary artery and descending thoracic aorta just distal to the left subclavian artery.

With transition from intrauterine to extrauterine life, physiological changes occur resulting in left to right reversal of the shunt through the ductus arteriosus. Increased oxygenation after birth results in calcium and potassium channel activity ending in ductus closure(2).

Patent ductus arteriosus (PDA ) is a congenital heart disease(CHD) represents 6-11% of all CHDs (3) and results from failure of closure of the ductus beyond the third month of age(4).

However, there are a subset of patients who survive to adulthood undiagnosed, and it is present in adulthood with various clinical presentations. The clinical presentation, hemodynamics, and management of PDA presentation in adults depend on various factors, primarily the size of PDA, magnitude of shunting, and status of pulmonary vasculature (5).

According to the diameter, and length of the duct, the systemic and pulmonary vascular resistance, the duct may be hemodynamically insignificant or may result in pulmonary over circulation with subsequent left sided heart volume overload(5).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • All adults and adolescent patients > 0r equal 12 yrs old who are candidate for trans-catheter PDA closure according to the latest European society of cardiology (ESC) and American Heart Associations (AHA) guidelines for management of patients with congenital heart diseases (CHD)(24).

排除标准

  • Patients with small sized PDA which is silent by auscultation.
  • Patients with large sized PDA which is unsuitable for Trans-catheter closure.
  • 3. Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).
  • 4. Patients with active infection or active infective endocarditis.
  • Patients refuse to participate in the study.
  • Patients with diabetes, systemic hypertension and ischemic heart diseases.
  • Patients with associated congenital or acquired cardiac lesions that may affect/interfere with the LV mechanics.

研究者

发起方
Emil Magdy Badry
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emil Magdy Badry

Hatem Abdelrahman

Assiut University

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