Effect of PDA Closure on the Left Ventricular Remodeling

Sponsor
Ahmed Mohamed Moheb El-Din (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04964531
Collaborator
(none)
48
19.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: speckle tracking echocardiography

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 .

Study Design

Study Type:
Observational
Anticipated Enrollment :
48 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Left Ventricular Remodeling After Transcatheter Closure of the Patent Ductus Arteriosus. Comparative Study Between Different Age Groups
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Adults

group of adults includes all patients aging 19 years or more

Other: speckle tracking echocardiography
before and after closure of the PDA , echocardiographic loops of the apical 4, 3 , and 2 chamber will be acquired then processed by special software for measuring the speckle movements in the longitudinal and short axis views

children

group of children includes all patients aging less than 19 years

Other: speckle tracking echocardiography
before and after closure of the PDA , echocardiographic loops of the apical 4, 3 , and 2 chamber will be acquired then processed by special software for measuring the speckle movements in the longitudinal and short axis views

Outcome Measures

Primary Outcome Measures

  1. change of LV strain after transcatheter closure of the PDA [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ahmed Mohamed Moheb El-Din

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Mohamed Moheb El-Din, Assistant lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT04964531
Other Study ID Numbers:
  • speckle tracking, PDA
First Posted:
Jul 16, 2021
Last Update Posted:
Jul 16, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 16, 2021