Effect of PDA Closure on the Left Ventricular Remodeling

July 6, 2021 updated by: Ahmed Mohamed Moheb El-Din

Left Ventricular Remodeling After Transcatheter Closure of the Patent Ductus Arteriosus. Comparative Study Between Different Age Groups

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

48

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of LV strain after transcatheter closure of the PDA
Time Frame: 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.
at base line, within 48 hours after closure of the duct then at three and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed Mohamed Moheb El-Din

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

February 1, 2023

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (ACTUAL)

July 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • speckle tracking, PDA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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