NCT07502196

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Apr 2026May 2027

First Submitted

Initial submission to the registry

March 25, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 25, 2026

Last Update Submit

March 25, 2026

Conditions

Keywords

Chronic Liver DiseaseLiver CirrhosisCardiac ProblemsPortopulmonary HypertensionCirrhotic CardiomyopathyCardiac Repolarization Abnormalities

Outcome Measures

Primary Outcomes (1)

  • Corrected QT (QTc) Interval

    The corrected QT (QTc) interval will be measured using an electrocardiogram (ECG) to evaluate for cardiac repolarization abnormalities.

    Baseline (at study enrollment)

Study Arms (1)

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.

Eligibility Criteria

AgeUp to 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • All patients below 18 years who diagnosed with chronic liver disease.

You may not qualify if:

  • All patients known to have congenital heart disease or previous cardiac disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Pediatric Department, Assiut University

Study Record Dates

First Submitted

March 25, 2026

First Posted

March 30, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03