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
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