Chronic Liver Disease (CLD)NCT07502196
Heart Problems in Children With Chronic Liver Disease
An observational study of Chronic Liver Disease (CLD) and Liver Cirrhosis, run by Assiut University.
Trial summary
Chronic liver disease (CLD) in children can sometimes lead to complications in other parts of the body, including the heart. The primary purpose of this observational study is to assess the presence and type of cardiac problems in children who have been diagnosed with chronic liver disease. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Chronic Liver Disease (CLD), Liver Cirrhosis, Cardiac Abnormalities
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to May 2027
- Phase
- Observational
- 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 17 years
- All sexes
- Child
Study population: The study population will consist of pediatric patients (under 18 years of age) diagnosed with chronic liver disease who are attending the gastroenterology and hepatology unit at Assiut University Children's Hospital. The population will include patients with various underlying causes of chronic liver disease, such as autoimmune hepatitis, viral hepatitis (B and C), Wilson's disease, and cystic fibrosis. Patients with known congenital heart disease or a history of previous cardiac disease will be excluded from this population.
Who may be able to join
- All patients below 18 years who diagnosed with chronic liver disease.
Who cannot join
- All patients known to have congenital heart disease or previous cardiac disease.
About this study
Official title: Assessment of Cardiac Problems in Children With Chronic Liver Disease
Chronic liver disease (CLD) in children can sometimes lead to complications in other parts of the body, including the heart. The primary purpose of this observational study is to assess the presence and type of cardiac problems in children who have been diagnosed with chronic liver disease.
Researchers will observe children under the age of 18 who are receiving care at the gastroenterology and hepatology unit at Assiut University Children Hospital. Participants will undergo standard medical evaluations to check both their liver and heart health.
Read more
These evaluations include:
- A detailed medical history and thorough physical examination
- Routine blood tests to check liver function, kidney function, coagulation, and electrolytes
- Abdominal imaging, such as an ultrasound, to look at the liver.
- An electrocardiogram (ECG) to check the heart's electrical activity and rhythm, including measuring the QTc interval.
- An echocardiogram to look at the structure of the heart and check how well its chambers and valves are functioning.
The study aims to identify specific heart conditions that can be associated with severe liver disease, such as portopulmonary hypertension, cirrhotic cardiomyopathy (changes in the heart muscle's function), and electrical repolarization abnormalities. Children who already have known congenital heart disease or a history of other heart problems will not be included in the study.
Read the detailed description
Chronic liver disease (CLD) in the pediatric age group involves progressive destruction and regeneration of liver parenchyma. The etiology in children encompasses a broad spectrum of disorders, including infections, autoimmune hepatitis, viral hepatitis, Wilson's disease, and biliary atresia. Prognosis and treatment are heavily influenced by the underlying etiology, necessitating thorough clinicopathological evaluation.
Among the severe reported complications of CLD, such as portal hypertension, malnutrition, and hepatorenal syndrome, cardiac complications are highly significant. This study specifically investigates the following cardiac issues:
- Portopulmonary hypertension: Defined as a mean pulmonary arterial pressure >25 mmHg and pulmonary capillary wedge pressure <15 mmHg, often presenting with dyspnea, fatigue, orthopnea, or chest pain. It is thought to be triggered by increased pulmonary blood flow secondary to portal hypertension, which leads to vascular injury and remodeling.
- Cirrhotic cardiomyopathy: A hemodynamic consequence of portal hypertension characterized by systolic and/or diastolic dysfunction, left ventricular hypertrophy, and electrophysiological disturbances. The underlying mechanism involves myocardial wall stiffness resulting from fibrosis and subendothelial edema.
- Cardiac repolarization abnormalities: Prolongation of the corrected QT (QTc) interval is the most common finding, with its prevalence increasing in parallel with the severity of cirrhosis. Up to 60% of patients with end-stage liver disease exhibit an abnormal QTc.
This descriptive cohort study aims to systematically assess these cardiac outcomes across different liver disease groups. Data collection involves comprehensive clinical histories, including age at onset, disease type semiology, and detailed physical examinations covering general, abdominal, cardiac, neurological, and chest assessments.
- Conditions
- Chronic Liver Disease (CLD), Liver Cirrhosis, Cardiac Abnormalities, Portopulmonary Hypertension, Cirrhotic Cardiomyopathy
- Keywords
- Chronic Liver Disease, Liver Cirrhosis, Cardiac Problems, Portopulmonary Hypertension, Cirrhotic Cardiomyopathy, Cardiac Repolarization Abnormalities
- Medical subject headings
- Liver Cirrhosis
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 Chronic Liver Disease | This cohort consists of patients under 18 years of age diagnosed with chronic liver disease attending the gastroenterology and hepatology unit at Assiut University Children Hospital. Participants will undergo standard baseline clinical evaluations and investigations to characterize their hepatic and cardiac profiles. These investigations include laboratory tests , abdominal imaging , electrocardiography (ECG) , and echocardiography. Patients with known congenital heart disease or previous cardiac disease are excluded from this cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected QT (QTc) Interval
The corrected QT (QTc) interval will be measured using an electrocardiogram (ECG) to evaluate for cardiac repolarization abnormalities.
Measured: Baseline (at study enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver Disease (CLD)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Gamal Thabet, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502196
- Sponsor's protocol ID
- Cardiac Problems in CLD
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiac Problems in Children With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT07502196
- Acronym / sponsor ID
- Cardiac Problems in CLD
- Conditions
- Chronic Liver Disease (CLD), Liver Cirrhosis, Cardiac Abnormalities, Portopulmonary Hypertension, Cirrhotic Cardiomyopathy
- Keywords
- Chronic Liver Disease, Liver Cirrhosis, Cardiac Problems, Portopulmonary Hypertension, Cirrhotic Cardiomyopathy, Cardiac Repolarization Abnormalities
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Mar 2026 (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.
Chronic liver disease (CLD) in children can sometimes lead to complications in other parts of the body, including the heart. The primary purpose of this observational study is to assess the presence and type of cardiac problems in children who have been diagnosed with chronic liver disease.
Researchers will observe children under the age of 18 who are receiving care at the gastroenterology and hepatology unit at Assiut University Children Hospital. Participants will undergo standard medical evaluations to check both their liver and heart health.
These evaluations include:
- A detailed medical history and thorough physical examination
- Routine blood tests to check liver function, kidney function, coagulation, and electrolytes
- Abdominal imaging, such as an ultrasound, to look at the liver.
- An electrocardiogram (ECG) to check the heart's electrical activity and rhythm, including measuring the QTc interval.
- An echocardiogram to look at the structure of the heart and check how well its chambers and valves are functioning.
The study aims to identify specific heart conditions that can be associated with severe liver disease, such as portopulmonary hypertension, cirrhotic cardiomyopathy (changes in the heart muscle's function), and electrical repolarization abnormalities. Children who already have known congenital heart disease or a history of other heart problems will not be included in the study.
Detailed description
Chronic liver disease (CLD) in the pediatric age group involves progressive destruction and regeneration of liver parenchyma. The etiology in children encompasses a broad spectrum of disorders, including infections, autoimmune hepatitis, viral hepatitis, Wilson's disease, and biliary atresia. Prognosis and treatment are heavily influenced by the underlying etiology, necessitating thorough clinicopathological evaluation.
Among the severe reported complications of CLD, such as portal hypertension, malnutrition, and hepatorenal syndrome, cardiac complications are highly significant. This study specifically investigates the following cardiac issues:
- Portopulmonary hypertension: Defined as a mean pulmonary arterial pressure >25 mmHg and pulmonary capillary wedge pressure <15 mmHg, often presenting with dyspnea, fatigue, orthopnea, or chest pain. It is thought to be triggered by increased pulmonary blood flow secondary to portal hypertension, which leads to vascular injury and remodeling.
- Cirrhotic cardiomyopathy: A hemodynamic consequence of portal hypertension characterized by systolic and/or diastolic dysfunction, left ventricular hypertrophy, and electrophysiological disturbances. The underlying mechanism involves myocardial wall stiffness resulting from fibrosis and subendothelial edema.
- Cardiac repolarization abnormalities: Prolongation of the corrected QT (QTc) interval is the most common finding, with its prevalence increasing in parallel with the severity of cirrhosis. Up to 60% of patients with end-stage liver disease exhibit an abnormal QTc.
This descriptive cohort study aims to systematically assess these cardiac outcomes across different liver disease groups. Data collection involves comprehensive clinical histories, including age at onset, disease type semiology, and detailed physical examinations covering general, abdominal, cardiac, neurological, and chest assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Chronic Liver Disease | – | –This cohort consists of patients under 18 years of age diagnosed with chronic liver disease attending the gastroenterology and hepatology unit at Assiut University Children Hospital. Participants will undergo standard baseline clinical evaluations and investigations to characterize their hepatic and cardiac profiles. These investigations include laboratory tests , abdominal imaging , electrocardiography (ECG) , and echocardiography. Patients with known congenital heart disease or previous cardiac disease are excluded from this cohort. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- The study population will consist of pediatric patients (under 18 years of age) diagnosed with chronic liver disease who are attending the gastroenterology and hepatology unit at Assiut University Children's Hospital. The population will include patients with various underlying causes of chronic liver disease, such as autoimmune hepatitis, viral hepatitis (B and C), Wilson's disease, and cystic fibrosis. Patients with known congenital heart disease or a history of previous cardiac disease will be excluded from this population.
Key inclusion criteria (1 listed)
- All patients below 18 years who diagnosed with chronic liver disease.
Key exclusion criteria (1 listed)
- All patients known to have congenital heart disease or previous cardiac disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Corrected QT (QTc) Interval
Time frame: Baseline (at study enrollment)
The corrected QT (QTc) interval will be measured using an electrocardiogram (ECG) to evaluate for cardiac repolarization abnormalities.
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 30 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease (CLD) and Liver Cirrhosis, run by Assiut University.
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 1 inclusion and 1 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corrected QT (QTc) Interval (time frame: Baseline (at study enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026.