NCT07678710

Brief Summary

The present study aimed to assess left ventricular myocardial dysfunction in children with chronic kidney disease using 2D and 3D speckle-tracking echocardiography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Left ventricular systolic function

    Left ventricular systolic function was evaluated by calculating the left ventricular ejection fraction (LVEF) using the biplane Simpson's method from apical four- and two-chamber views.

    At baseline

Study Arms (1)

Study group

Children with end-stage chronic kidney disease (CKD) on regular maintenance hemodialysis.

Device: Two-Dimensional Speckle-Tracking Echocardiography (2D-STE)Device: Three-Dimensional Speckle-Tracking Echocardiography (3D-STE)

Interventions

2D speckle-tracking echocardiography was used to assess left ventricular myocardial deformation. Standard apical four-, two-, and three-chamber views were acquired with optimized frame rates.

Study group

Three-dimensional datasets were acquired from apical full-volume images, ensuring optimal electrocardiographic gating, adequate frame rates, and high-quality image acquisition.

Study group

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This prospective observational study was conducted at the pediatric cardiology and nephrology units of Al-Hussain and Bab El-Shaaria University Hospitals, Al-Azhar University, Cairo, Egypt from January 2025 to August 2025.

You may qualify if:

  • Age between 4 and 18 years.
  • Children with chronic kidney disease (CKD) receiving regular hemodialysis for ≥1 year.

You may not qualify if:

  • Presence of structural or congenital heart disease.
  • Patients with poor echocardiographic window or arrhythmias interfering with image acquisition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University

Cairo, 11651, Egypt

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Paediatrics, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

January 1, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations