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

2026年4月28日 更新者:Emil Magdy Badry

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).

研究概览

详细说明

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).

This volume overload induces left heart remodeling manifested by left atrial and ventricular dilatation and hypertrophy to compensate for the increased wall stress. Some patients can compensate well and remain asymptomatic, while others can't and develop heart failure and LV systolic dysfunction (6).

Traditional two dimensional (2D) and doppler echocardiography is the cornerstone tool for the diagnosis of PDA, evaluation of the magnitude and direction of its shunting, and measuring the pulmonary artery pressure(6). Speckle tracking echocardiography (STE) is a relatively novel application that helps in the assessment of the LV and RV function by tracking the speckles seen on the grey scale images of the traditional echocardiography (7). Recent studies showed good correlation between the global longitudinal strain (GLS) measured by the STE , left and Right ventricular ejection fraction (LVEF , RVEF ) measured by traditional 2D echocardiography (8). In addition, other studies revealed that STE could detect subtle myocardial dysfunction in heart failure patients with preserved LVEF (9).

Since the first surgical PDA closure by Gross and Hubbard in 1939 and the later transcatheter PDA closure by Portsmann et al. in 1967, there have been many significant developments in the devices used to close a PDA(10)(11) . In the past 20 years, transcatheter closure has become the leading approach to closure of most PDAs(12).

Complete closure rates at follow-up generally exceed 90- 95% in most studies. Serious complications of transcatheter closure of the PDA are rare.

In real world, cardiologists intervene adult patients with PDAs and have access to variable PDA closure coils and devices that can be implanted through different techniques and theoretically this should induce reverse LV remodeling with improvement of the Left heart dimensions and function (13). Fewer studies assessed the adults with PDA and their findings were late improvement of the LVEF after PDA closure (15,16,23)

研究类型

观察性的

注册 (估计的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Emil Magdy Badry, Resident doctor
  • 电话号码:+20 12 75470803
  • 邮箱:emilmagdy27@gmail.com

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

概率样本

研究人群

Patients with patent ductus arteriosus

描述

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • - 1. Patients with small sized PDA which is silent by auscultation. 2. 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. 5. Patients refuse to participate in the study. 6. Patients with diabetes, systemic hypertension and ischemic heart diseases. 7. Patients with associated congenital or acquired cardiac lesions that may affect/interfere with the LV mechanics.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
left atrial and ventricular Remodeling in Adults
Transcatheter Patent Ductus Arteriosus Closure

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change in myocardial strain parameters in lt atrium and ventricle before and after PDA ligation
大体时间:From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • 1. Morton S, Brodsky D. Fetal Physiology and the Transition to Extrauterine Life. 2. Weir EK, Obreztchikova M, Vargese A, Cabrera JA, Peterson DA, Hong Z. Mechanisms of oxygen sensing: A key to therapy of pulmonary hypertension and patent ductus arteriosus. Vol. 155, British Journal of Pharmacology. 2008. p. 300-7. 3. P S, Jose J, George OK. Contemporary outcomes of percutaneous closure of patent ductus arteriosus in adolescents and adults. Indian Heart J. 2018 Mar 1;70(2):308-15. 4. Forsey JT, Elmasry OA, Martin RP. Patent arterial duct. Orphanet J Rare Dis. 2009;4(1):1-9. 5. Schneider DJ, Moore JW. Patent Ductus Arteriosus. 2006 [cited 2021 Apr 4]; Available from: http://www.circulationaha.org 6. Schneider DJ. The Patent Ductus Arteriosus in Term Infants, Children, and A dults. Semin Perinatol [Internet]. 2012;36(2):146-53. Available from: http://dx.doi.org/10.1053/j.semperi.2011.09.025 7. Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux GG, et al. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese society of echocardiography. Eur J Echocardiogr [Internet]. 2011 Mar [cited 2017 Mar 25];12(3):167-205. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0894731711000484 8. Mondillo S, Galderisi M, Mele D, Cameli M, Lomoriello VS, Zacà V, et al. Speckle-tracking echocardiography: a new technique for assessing myocardial function. J Ultrasound Med [Internet]. 2011 Jan [cited 2018 Jul 14];30(1):71-83. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21193707 9. Edvardsen T, Helle-Valle T, Smiseth OA. Systolic Dysfunction in Heart Failure with Normal Ejection Fraction: Speckle-Tracking Echocardiography. Prog Cardiovasc Dis. 2006 Nov;49(3):207-14. 10. Gross RE, Hubbard JP. Surgical ligation of a patent ductus arteriosus: Report of first successful case. J Am Med Assoc. 1939 Feb 25;112(8):729-3

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月3日

初级完成 (估计的)

2028年6月3日

研究完成 (估计的)

2028年7月4日

研究注册日期

首次提交

2026年4月21日

首先提交符合 QC 标准的

2026年4月28日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年5月5日

上次提交的符合 QC 标准的更新

2026年4月28日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • Adult transcatheter PDA close

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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