Prevalence of Liver Dysfunction in Pediatric Patients With Congenital Heart Disease at Assiut.

NCT07144501 | Not Yet Recruiting DMC

• 2 other identifiers: YNMA22491Assiut University
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Liver dysfunction is a well-documented complication in patients with congenital heart disease (CHD). The mechanisms leading to hepatic dysfunction may be multifactorial. Key risk factors for liver dysfunction in CHD include prolonged hypoxemia, high venous pressure, and prolonged duration of heart disease. While global studies have extensively explored this association, the prevalence of liver dysfunction in CHD varies, with studies reporting hepatic fibrosis in 30-40% of Fontan patients, while regional data, particularly from Egypt, remain limited. In this research we aim to determine the prevalence of biochemical and radiological hepatic abnormalities in pediatric CHD patients attending Assiut University Children's Hospital.

Conditions

Congenital Heart Disease; Liver Dysfunction

Keywords

CHD; Liver dysfunction

Outcome Measures

Primary Outcomes (1)

• To assess the prevalence of hepatic dysfunction among CHD

  To assess the prevalence of hepatic dysfunction among CHD patients attending Assiut University Children's Hospital

  5 months

Secondary Outcomes (1)

• To classify hepatic dysfunction with CHD

  4 months

Study Arms (1)

CHD patients

EXPERIMENTAL

A- Full History Taking: B- General Examination: C- Cardiac Examination: 1. Physical examination 2. Echocardiography D- Hepatic Examination: 1. Physical examination 2. Biochemical Markers: To assess hepatic function in congenital heart disease (CHD) patients, blood samples will be collected from all patients in our study 3. Abdominal ultrasound:

Diagnostic Test: Ultrasonography; Procedure: Blood Sampling

Interventions

Ultrasonography DIAGNOSTIC_TEST

Ultrasound, also known as sonography or ultrasonography, is a medical imaging technique that uses high-frequency sound waves to create real-time images of internal body structures

CHD patients

Blood Sampling PROCEDURE

To assess hepatic function in congenital heart disease (CHD) patients, blood samples will be collected from all patients in our study for: * Alanine Transferase (ALT). * Aspartate Aminotransferase (AST). * Gamma Glutamyl Transferase (GGT). * Alkaline Phosphatase (ALP). * Total/direct bilirubin. * Albumin. * Prothrombin time. * International Normalized Ratio (INR). * Platelet count.

CHD patients

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Confirmed pediatric CHD patients attending Assiut University Children's Hospital.
• Age: from birth up to 16 years old.

You may not qualify if:

• Patients with primary liver disease.
• Recent cardiac surgery (\<3 m) (to exclude acute postoperative liver injury).
• Active systemic infection/sepsis (to avoid confounding liver enzyme elevations).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Children Hospital.

Asyut, Assiut City, Egypt

Location

Related Publications (1)

• Malatino LS, Fiore CE, Costa M, Calandra C, Petrone G, Cacciola S. Circadian rhythm of plasma tryptophan in clinically healthy subjects and patients with endogenous depression. Chronobiologia. 1982 Jan-Mar;9(1):13-20.

  PMID: 7140474 BACKGROUND

Related Links

• relationship between Congenital heart disease and the liver

MeSH Terms

Conditions

Heart Defects, Congenital; Liver Diseases

Interventions

Ultrasonography; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Duaa Raafat, Professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmin Nassar, Doctor

CONTACT

01090356527; dr.yasminnassar@gmail.com

Ahmed Zuhry, Lecturer

CONTACT

01010168440; Ahmedzuhry3990@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 27, 2025
• Study Start: September 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 15, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)