Role of Echocardiography in the Assessment of Right Ventricular Function in the Pediatric Population With Valvular Pulmonary Stenosis.

July 2, 2021 updated by: Saad Abdelhafiz Abdelsalam, Assiut University

Role of Echocardiography in the Assessment of Right Ventricular Function in the Pediatric Population With Valvular Pulmonary Stenosis After Percutaneous Balloon Pulmonary Valvuoplasty.

Correct assessment of right ventricular function by transthoracic echocardiographic examination in pediatric patients with congenital valvular pulmonary stenosis after Percutaneous Balloon Pulmonary Valvuloplasty

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The right ventricle plays an important role in the morbidity and mortality of patients presenting with signs and symptoms of cardiopulmonary disease. However, the systematic assessment of right heart function is not uniformly carried out. This is due partly to the enormous attention given to the evaluation of the left heart, a lack of familiarity with ultrasound techniques that can be used in imaging the right heart, and a paucity of ultrasound studies providing normal reference values of right heart size and function. In patients with CHD, the right ventricle (RV) may function as either the sub-pulmonary or the systemic ventricle as in transposition of great arteries (TGA). CHD more commonly affecting the right heart includes atrial septal defects (ASD), Tetralogy of Fallot (TOF), pulmonary stenosis (PS), Ebstein anomaly, arrhythmogenic right ventricular cardiomyopathy (ARVC), and pulmonary valve atresia. In many of these patients, prevention of "irreversible" right heart failure (RHF) will require timely corrective surgery or when not possible, surgical palliation . Congenital pulmonary valve stenosis is a common congenital heart disease. Isolated pulmonary valve stenosis comprises 8-10% of all congenital heart disease . While surgical pulmonary valvotomy has been available as a treatment since 1956, it requires a median sternotomy, use of cardiopulmonary bypass, and post-surgical ICU admission with multi-day hospitalization. Recognizing the potential advantages of a less invasive approach, the first attempts at percutaneous catheter-based dilation of stenotic pulmonary valves were performed in the 1950s. As the technique was refined and catheter and balloon technology have advanced, the results of balloon pulmonary valvuloplasty have improved and the approach has become the standard of care for treating pulmonary valve stenosis

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Nagwa Ali Mohamed, prof (MD)
  • Phone Number: 01096260950
  • Email: Namma65@yahoo.com

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

1 month to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pediatric patients with valvular pulmonary stenosis who will undergo trans cutaneous pulmonary valvuloplasty

Description

Inclusion Criteria:

  • All pediatric patients with congenital valvular pulmonary stenosis attending echocardiographic outpatient clinic of Assuit University children hospital aged from one month to18 years old

Exclusion Criteria:

Age less than one month and older than 18 years. Patients with infundibular and supravalvular pulmonary stenosis

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between right ventricular dysfunction and severity of valvular pulmonary stenosis
Time Frame: baseline
tissue Doppler of the right ventricle before and after trans cutaneous pulmonary valvuloplasty
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

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 2, 2021

Primary Completion (ANTICIPATED)

July 2, 2022

Study Completion (ANTICIPATED)

August 2, 2022

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (ACTUAL)

July 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • echo in RV function

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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