Clinical trial NCT04964531: Effect of PDA Closure on the Left Ventricular Remodeling
Official title: Left Ventricular Remodeling After Transcatheter Closure of the Patent Ductus Arteriosus. Comparative Study Between Different Age Groups
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Defect
Patent Ductus Arteriosus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study population will include all patients diagnosed as having patent ductus arteriosus and this ductus either hemodynamically insignificant but with audible murmur or this duct causes left heart volume overload symptoms

Brief 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.

Detailed 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 .

Eligibility criteria: Inclusion Criteria:

* all patients who are candidate for transcatheter PDA closure.

Exclusion Criteria:

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

Primary outcomes:
measure: change of LV strain after transcatheter closure of the PDA
timeFrame: at base line, within 48 hours after closure of the duct then at three and six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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