Left Ventricular Myocardial DysfunctionNCT07678710
Assessment of Left Ventricular Myocardial Dysfunction in Children With End-Stage Kidney Disease Using Two-Dimensional and Three-Dimensional Speckle-Tracking Echocardiography
An observational study of Left Ventricular Myocardial Dysfunction and End-Stage Kidney Disease, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The present study aimed to assess left ventricular myocardial dysfunction in children with chronic kidney disease using 2D and 3D speckle-tracking echocardiography. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Left Ventricular Myocardial Dysfunction, End-Stage Kidney Disease, Two-Dimensional Speckle-Tracking Echocardiography
- What is being tested?
- Two-Dimensional Speckle-Tracking Echocardiography (2D-STE) and Three-Dimensional Speckle-Tracking Echocardiography (3D-STE)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Age between 4 and 18 years.
- Children with chronic kidney disease (CKD) receiving regular hemodialysis for ≥1 year.
Who cannot join
- Presence of structural or congenital heart disease.
- Patients with poor echocardiographic window or arrhythmias interfering with image acquisition.
Trial locations and contacts
1 site in 1 country.
About this study
The present study aimed to assess left ventricular myocardial dysfunction in children with chronic kidney disease using 2D and 3D speckle-tracking echocardiography.
Read the detailed description
Chronic kidney disease (CKD) is a complex and multifaceted disease that causes renal dysfunction and progression to end-stage kidney disease.
Cardiovascular risk is common in patients with end-stage renal disease on hemodialysis, many studies have shown that the risk of adverse cardiovascular events is significantly increased and persistent in all patients treated with hemodialysis, especially those who have just started hemodialysis treatment.
Patients with end-stage renal disease have elevated levels of cardiac biomarkers, despite no apparent signs of cardiac dysfunction or radial damage; this is related to chronic kidney disease comorbidities and reduced renal clearance per se.
- Conditions
- Left Ventricular Myocardial Dysfunction, End-Stage Kidney Disease, Two-Dimensional Speckle-Tracking Echocardiography, Three-Dimensional Speckle-Tracking Echocardiography, Children
- Being tested
- Two-Dimensional Speckle-Tracking Echocardiography (2D-STE), Three-Dimensional Speckle-Tracking Echocardiography (3D-STE)
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-Dimensional Speckle-Tracking Echocardiography (2D-STE)Device
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.
Three-Dimensional Speckle-Tracking Echocardiography (3D-STE)Device
Three-dimensional datasets were acquired from apical full-volume images, ensuring optimal electrocardiographic gating, adequate frame rates, and high-quality image acquisition.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Children with end-stage chronic kidney disease (CKD) on regular maintenance hemodialysis. Receives: Device: Two-Dimensional Speckle-Tracking Echocardiography (2D-STE); Device: Three-Dimensional Speckle-Tracking Echocardiography (3D-STE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jan 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Myocardial DysfunctionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Abdelraheem Elsayed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678710
- Sponsor's protocol ID
- 293
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Left Ventricular Myocardial Dysfunction in Children With End-Stage Kidney Disease Using Two-Dimensional and Three-Dimensional Speckle-Tracking Echocardiography
- ClinicalTrials.gov ID
- NCT07678710
- Acronym / sponsor ID
- 293
- Conditions
- Left Ventricular Myocardial Dysfunction, End-Stage Kidney Disease, Two-Dimensional Speckle-Tracking Echocardiography, Three-Dimensional Speckle-Tracking Echocardiography, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aimed to assess left ventricular myocardial dysfunction in children with chronic kidney disease using 2D and 3D speckle-tracking echocardiography.
Detailed description
Chronic kidney disease (CKD) is a complex and multifaceted disease that causes renal dysfunction and progression to end-stage kidney disease.
Cardiovascular risk is common in patients with end-stage renal disease on hemodialysis, many studies have shown that the risk of adverse cardiovascular events is significantly increased and persistent in all patients treated with hemodialysis, especially those who have just started hemodialysis treatment.
Patients with end-stage renal disease have elevated levels of cardiac biomarkers, despite no apparent signs of cardiac dysfunction or radial damage; this is related to chronic kidney disease comorbidities and reduced renal clearance per se.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Two-Dimensional Speckle-Tracking Echocardiography (2D-STE), Device: Three-Dimensional Speckle-Tracking Echocardiography (3D-STE)Children with end-stage chronic kidney disease (CKD) on regular maintenance hemodialysis. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Age between 4 and 18 years.
- Children with chronic kidney disease (CKD) receiving regular hemodialysis for ≥1 year.
Key exclusion criteria (2 listed)
- Presence of structural or congenital heart disease.
- Patients with poor echocardiographic window or arrhythmias interfering with image acquisition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two-Dimensional Speckle-Tracking Echocardiography (2D-STE)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. | Device | Study group |
| Three-Dimensional Speckle-Tracking Echocardiography (3D-STE)Three-dimensional datasets were acquired from apical full-volume images, ensuring optimal electrocardiographic gating, adequate frame rates, and high-quality image acquisition. | Device | Study group |
Primary outcome
Left ventricular systolic function
Time frame: At baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Myocardial Dysfunction and End-Stage Kidney Disease, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular systolic function (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.