- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07678710
Assessment of Left Ventricular Myocardial Dysfunction in Children With End-Stage Kidney Disease Using Two-Dimensional and Three-Dimensional Speckle-Tracking Echocardiography
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 11651
- Al-Azhar University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 4 and 18 years.
- Children with chronic kidney disease (CKD) receiving regular hemodialysis for ≥1 year.
Exclusion Criteria:
- Presence of structural or congenital heart disease.
- Patients with poor echocardiographic window or arrhythmias interfering with image acquisition.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study group
Children with end-stage chronic kidney disease (CKD) on regular maintenance hemodialysis.
|
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 datasets were acquired from apical full-volume images, ensuring optimal electrocardiographic gating, adequate frame rates, and high-quality image acquisition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Pathological Conditions, Signs and Symptoms
- Kidney Failure, Chronic
Other Study ID Numbers
- 293
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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