Congenital Heart DiseaseNCT07866924
Echocardiographic Assessment of Valvular Dysfunction in Children With CHD
An observational study of Congenital Heart Disease and Valvular Heart Disease, run by Assiut University.
Trial summary
This cross-sectional study aims to assess the type and severity of valvular dysfunction by echocardiography in children with congenital heart disease. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Congenital Heart Disease, Valvular Heart Disease
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 1 month to 18 years with congenital heart disease attending the Cardiology Department of Assiut University Children Hospital.
Who may be able to join
- - Children with congenital heart disease
- Age from 1 month to 18 years
- Written informed consent from parents or legal guardians
Who cannot join
- - Rheumatic heart disease
- Any type of cardiomyopathy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Echocardiographic Assessment of Valvular Dysfunction in Children With Congenital Heart Disease
This cross-sectional study aims to assess the type and severity of valvular dysfunction by echocardiography in children with congenital heart disease.
Read the detailed description
Valvular dysfunction is common in children with congenital heart disease and may include stenosis, regurgitation, or mixed lesions. Echocardiography is the primary non-invasive method for evaluating valve morphology and hemodynamics.
This observational study will perform comprehensive echocardiographic assessment in children aged 1 month to 18 years with congenital heart disease to determine the prevalence and characteristics of valvular dysfunction.
- Conditions
- Congenital Heart Disease, Valvular Heart Disease
- Keywords
- Congenital heart disease, Echocardiography, Children, Valvular dysfunction, Assiut
- Medical subject headings
- Heart Defects, Congenital, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with Congenital Heart Disease | Children aged 1 month to 18 years with congenital heart disease undergoing echocardiographic assessment of valvular function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of valvular dysfunction
Percentage of children with congenital heart disease who have any valvular stenosis or regurgitation on echocardiography.
Measured: Baseline
Secondary outcomes (4)
Frequency of aortic valve dysfunction
Percentage of children with aortic stenosis or aortic regurgitation on echocardiography.
Measured: Baseline
Frequency of pulmonary valve dysfunction
Percentage of children with pulmonary stenosis or pulmonary regurgitation on echocardiography.
Measured: Baseline
Frequency of mitral valve dysfunction
Percentage of children with mitral stenosis or mitral regurgitation on echocardiography.
Measured: Baseline
Frequency of tricuspid valve dysfunction
Percentage of children with tricuspid stenosis or tricuspid regurgitation on echocardiography.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sayed Abd Elwareth, Assiut University
- Investigators
- Salah eldin A Ahmed, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866924
- Sponsor's protocol ID
- Valve-CHD-Assiut-2026
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Assessment of Valvular Dysfunction in Children With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT07866924
- Acronym / sponsor ID
- Valve-CHD-Assiut-2026
- Conditions
- Congenital Heart Disease, Valvular Heart Disease
- Keywords
- Congenital heart disease, Echocardiography, Children, Valvular dysfunction, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 8 Oct 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.
This cross-sectional study aims to assess the type and severity of valvular dysfunction by echocardiography in children with congenital heart disease.
Detailed description
Valvular dysfunction is common in children with congenital heart disease and may include stenosis, regurgitation, or mixed lesions. Echocardiography is the primary non-invasive method for evaluating valve morphology and hemodynamics.
This observational study will perform comprehensive echocardiographic assessment in children aged 1 month to 18 years with congenital heart disease to determine the prevalence and characteristics of valvular dysfunction.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Congenital Heart Disease | – | –Children aged 1 month to 18 years with congenital heart disease undergoing echocardiographic assessment of valvular function. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 1 month to 18 years with congenital heart disease attending the Cardiology Department of Assiut University Children Hospital.
Key inclusion criteria (3 listed)
- - Children with congenital heart disease
- Age from 1 month to 18 years
- Written informed consent from parents or legal guardians
Key exclusion criteria (2 listed)
- - Rheumatic heart disease
- Any type of cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of valvular dysfunction
Time frame: Baseline
Percentage of children with congenital heart disease who have any valvular stenosis or regurgitation on echocardiography.
4 secondary outcomes
Frequency of aortic valve dysfunction
Time frame: Baseline
Frequency of pulmonary valve dysfunction
Time frame: Baseline
Frequency of mitral valve dysfunction
Time frame: Baseline
Frequency of tricuspid valve dysfunction
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Disease
Recruiting
Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
Congenital Heart Disease
Active, not recruiting
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
Active, not recruiting
Autus Valve Pivotal Study
Congenital Heart Disease
Active, not recruiting
Autus Valve Continued Access Study (CAS)
Congenital Heart Disease
Enrolling by invitationObservational study
Global Utilization And Registry Database for Improved heArt preservatioN
Heart Diseases, Heart Failure
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.
Salah eldin A Ahmed, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Valvular Heart Disease, run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed S Abelwarith, Resident (+20 10 13000660, mohamed.18313430@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of valvular dysfunction (time frame: 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 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.