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

Prevalence of Liver Dysfunction in Paediatric Patients With Congenital Heart Disease: A Cross-Sectional Study at Assiut University Children Hospital.

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07144501
Acronym
CHD
Enrollment
40
Registered
2025-08-27
Start date
2025-09-15
Completion date
2026-03-15
Last updated
2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease, Liver Dysfunction

Keywords

CHD, Liver dysfunction

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.

Detailed description

Liver dysfunction is a well-documented complication in patients with congenital heart disease (CHD), primarily due to chronic venous congestion, reduced cardiac output, and hypoxemia. The pathophysiology involves hepatic congestion secondary to right-sided heart failure, leading to fibrosis and cirrhosis in advanced cases. While global studies have extensively explored this association, regional data, particularly from Egypt, remain limited. In this research we aim to investigate liver dysfunction in CHD patients, with a specific focus on research conducted in Assiut, Egypt, to address gaps in localized clinical understanding. Hepatic complications are common in patients with CHD, resulting either from the primary cardiac defect or from palliative surgical procedures performed in infancy or childhood or from transfusion- or drug-related hepatitis. Given that such patients increasingly require the expertise of a hepatologist. There are several known associations between primary liver disease and concomitant CHD defects such as Abernethy malformation, Alagille syndrome, and Biliary Atresia Splenic Malformation syndrome (BASM). However, hepatic disease as a result of CHD is more common than cardiac disease associated with liver disease. In these cases, hepatic dysfunction may ensue as a result of the primary cardiac defect or as a result of surgical palliation, especially in patients with single-ventricle physiology (e.g., tricuspid atresia). The mechanisms leading to hepatic dysfunction may be multifactorial. As an example, hepatic dysfunction may result from a combination of passive venous congestion of the liver and hypoxia, with the latter being driven by the CHD or concomitant pulmonary disease. Volume overload and low cardiac output may lead to both congestive hepatopathy and hepatic ischemia. Several factors may interact to lead to end-stage liver disease. For example, patients with underlying liver disease (e.g., viral hepatitis, alcohol, or obesity) may be more susceptible to liver injury as a result of decreased functional mass. In addition, the presence of cardiac disease and subsequent passive congestion may itself predispose the liver to hepatic injury. Hypoxemia in cyanotic CHD further aggravates hepatocellular damage, necessitating routine hepatic monitoring in this population. Globally, the prevalence of liver dysfunction in CHD varies, with studies reporting hepatic fibrosis in 30-40% of Fontan patients. Data from developing regions, including Egypt, are scarce. A recent study highlighted elevated liver enzymes in CHD patients, emphasizing the role of delayed surgical intervention in disease progression. Such findings underscore the necessity for expanded research on hepatic complications in Egyptian CHD cohorts. Key risk factors for liver dysfunction in CHD include prolonged hypoxemia, high venous pressure, and prolonged duration of heart disease. Cyanotic CHD patients exhibit higher hepatic injury markers compared to acyanotic counterparts. In Egypt, socioeconomic barriers often delay corrective surgeries, exacerbating hepatic damage. Early intervention and regular hepatic surveillance are critical to improving outcomes. Despite global advancements, Egyptian studies on CHD-related liver dysfunction are limited. A 2016 Cairo University study identified a high prevalence of abnormal liver function tests among CHD patients but lacked longitudinal follow-up. Further research is needed to establish region-specific diagnostic and therapeutic protocols, considering local healthcare challenges.

Interventions

DIAGNOSTIC_TESTUltrasonography

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

PROCEDUREBlood Sampling

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
To assess the prevalence of hepatic dysfunction among CHD5 monthsTo assess the prevalence of hepatic dysfunction among CHD patients attending Assiut University Children's Hospital

Secondary

MeasureTime frameDescription
To classify hepatic dysfunction with CHD4 monthsTo classify hepatic dysfunction with CHD using the APRI index into mild, moderate, and severe.

Countries

Egypt

Contacts

Primary ContactYasmin Nassar, Doctor
dr.yasminnassar@gmail.com01090356527
Backup ContactAhmed Zuhry, Lecturer
Ahmedzuhry3990@aun.edu.eg01010168440

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026