Effect of PDA Closure on the Left Ventricular Remodeling

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04964531
Study type	Observational
Source	Assiut University
Contact
Status	Not yet recruiting
Phase
Start date	July 2021
Completion date	February 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04986839` - PAIR (Paracetamol and Ibuprofen Research) Pilot Trial	Phase 2/Phase 3
Recruiting	`NCT03648437` - Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus	Phase 1
Completed	`NCT04126512` - Timing of Surgical PDA Ligation and Neonatal Outcomes
Not yet recruiting	`NCT06045130` - PUFAs in Preterm Infants
Completed	`NCT00217191` - Ibuprofen and Renal Function in Premature Infants	Phase 4
Not yet recruiting	`NCT02894970` - A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation	N/A
Completed	`NCT02621528` - Lifetech CeraFlex™ Post-Market Surveillance Study	N/A
Completed	`NCT03551600` - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Terminated	`NCT03982342` - Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants	N/A
Completed	`NCT01479218` - Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus	N/A
Completed	`NCT00795990` - Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants	N/A
Withdrawn	`NCT00554307` - Brain, Gut and Kidney Blood Flow During Medical Closure of PDA	N/A
Terminated	`NCT00802685` - Timing of PDA Closure and Respiratory Outcome in Premature Infants	N/A
Completed	`NCT03723889` - Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
Recruiting	`NCT04397913` - Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
Completed	`NCT02750228` - PDA Post NICU Discharge
Recruiting	`NCT02220270` - Hyperion™ International Registry Trial	N/A
Completed	`NCT01593163` - Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus	Phase 3
Completed	`NCT03277768` - Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
Completed	`NCT03022253` - Platelet Transfusion for Treatment of Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates	Phase 3