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Status unknownNCT03850223Updated Feb 24, 2020

Clinical Audit On Management Of Congenital Heart Disease In ACUH

An observational study in Congenital Heart Disease, sponsored by Assiut University. Status unknown. Open to participants aged 1 Month to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-24.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
1 Month to 18 Years
Sex
All
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Study summary

Congenital Heart Disease (CHD) is the most common birth defect in the United States, affecting approximately 0.8% of live births. Improved treatment strategies and interventions have increased survival such that 85% to 90% of affected children are expected to live well into adulthood, thereby causing a demographic shift in which adults now outnumber children with CHD, and more people with complex CHD are living longer.

Read the detailed description

CHD may be defined as an anatomic malformation of the heart or great vessels which occurs during intrauterine development, irrespective of the age at presentation. The cause of most congenital heart defects is still unknown. Many cases of congenital heart disease are multifactorial and result from a combination of genetic predisposition and an environmental stimulus. A small percentage of congenital heart lesions are related to known chromosomal abnormalities, in particular, trisomy 21, 13, and 18 and Turner syndrome. Of all cases of congenital heart disease, 2-4% are associated with known environmental or adverse maternal conditions and teratogenic influences, including maternal diabetes mellitus, phenylketonuria, systemic lupus erythematosus or congenital rubella syndrome; and maternal ingestion of drugs (lithium, ethanol, warfarin, antimetabolites, vitamin A derivatives, anticonvulsant agents).

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Conditions studied

  • Congenital Heart Disease
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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 100 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Children with congenital heart disease more than one month and less than 18 years

Inclusion criteria

  • children with CHD more than one month

Exclusion criteria

Exclusion Criteria:

  • children with CHD less than one month
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Clinical audit study to assess management of congenital heart disease in AUCH

    To assess how much the adopted protocol of management of congenital heart disease is implemented in Assiut university children hospital

    Time frame: One year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03850223
Lead sponsor
Assiut University
Responsible party
Fadwa Magdy Mohamed Abdou (Principle investigator, Assiut University) — Principal investigator
First posted
Feb 21, 2019
Start date
Mar 1, 2020 (estimated)
Primary completion
Oct 1, 2021 (estimated)
Completion
Dec 1, 2021 (estimated)
Last update
Feb 24, 2020

Study contacts

Mostafa Shafeek Khalaf, Professor
Contact
mostafa.tawfeek1@med.au.edu.eg
+201112110096
Khaled Abdelaziz Sanusy, Assistant Professor
Contact
khalids@aun.edu.eg
+201003068421

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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