Congenital Heart DiseaseCHDNCT07144501
Prevalence of Liver Dysfunction in Pediatric Patients With Congenital Heart Disease at Assiut.
A study testing Ultrasonography and Blood Sampling in people with Congenital Heart Disease and Liver Dysfunction, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Congenital Heart Disease, Liver Dysfunction
- What is being tested?
- Ultrasonography and Blood Sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2025to 15 Mar 2026
- Phase
- Interventional
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed pediatric CHD patients attending Assiut University Children's Hospital.
- Age: from birth up to 16 years old.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Children Hospital.
Asyut, Assiut City
Yasmin Nassar, doctor, +201090356527, dr.yasminnassar@gmail.com
Ahmed Zuhry, Lecturer, +201010168440, Ahmedzuhry3990@aun.edu.eg
About this study
Official title: Prevalence of Liver Dysfunction in Paediatric Patients With Congenital Heart Disease: A Cross-Sectional Study at Assiut University Children Hospital.
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.
Read the 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.
- Conditions
- Congenital Heart Disease, Liver Dysfunction
- Being tested
- Ultrasonography, Blood Sampling
- Keywords
- CHD, Liver dysfunction
- Medical subject headings
- Heart Defects, Congenital, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic 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
Blood SamplingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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: Receives: Diagnostic Test: Ultrasonography; Procedure: Blood Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 months
Secondary outcomes (1)
To classify hepatic dysfunction with CHD
To classify hepatic dysfunction with CHD using the APRI index into mild, moderate, and severe.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Nassar Mohamed Ahmed, Assiut University
- Investigators
- Duaa Raafat, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144501
- Sponsor's protocol ID
- YNMA22491
- Other IDs
- Assiut University
- Acronym
- CHD
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The policy of data confidentiality will be strictly followed with anonymous and secure data storage.
Publications
El Hadi H, Di Vincenzo A, Vettor R, Rossato M. Relationship between Heart Disease and Liver Disease: A Two-Way Street. Cells. 2020 Feb 28;9(3):567. doi: 10.3390/cells9030567.
PubMed 32121065
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Liver Dysfunction in Paediatric Patients With Congenital Heart Disease: A Cross-Sectional Study at Assiut University Children Hospital.
- ClinicalTrials.gov ID
- NCT07144501
- Acronym / sponsor ID
- CHD / YNMA22491
- Conditions
- Congenital Heart Disease, Liver Dysfunction
- Keywords
- CHD, Liver dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 27 Aug 2025 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHD patients | Experimental | Diagnostic Test: Ultrasonography, Procedure: Blood SamplingA- 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: |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Confirmed pediatric CHD patients attending Assiut University Children's Hospital.
- Age: from birth up to 16 years old.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyUltrasound, 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 | Diagnostic test | CHD patients |
| Blood SamplingTo 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. | Procedure or surgery | CHD patients |
Primary outcome
To assess the prevalence of hepatic dysfunction among CHD
Time frame: 5 months
To assess the prevalence of hepatic dysfunction among CHD patients attending Assiut University Children's Hospital
1 secondary outcome
To classify hepatic dysfunction with CHD
Time frame: 4 months
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 27 Aug 2025.
- Results publication: PubMed 32121065El Hadi H, Di Vincenzo A, Vettor R, Rossato M. Relationship between Heart Disease and Liver Disease: A Two-Way Street. Cells. 2020 Feb 28;9(3):567. doi: 10.3390/cells9030567.
- relationship between Congenital heart disease and the liverLink provided by the sponsor.
- Individual participant dataSharing planned: No. The policy of data confidentiality will be strictly followed with anonymous and secure data storage.
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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.
Duaa Raafat, Professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography and Blood Sampling in people with Congenital Heart Disease and Liver Dysfunction, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 3 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 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yasmin Nassar, Doctor (01090356527, dr.yasminnassar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the prevalence of hepatic dysfunction among CHD (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07144501, which also lists 1 linked publication.
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 27 Aug 2025.