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Набор скоро начнётся NCT07502196

Heart Problems in Children With Chronic Liver Disease

Наблюдательное Chronic Liver Disease (CLD) Liver Cirrhosis Cardiac Abnormalities Portopulmonary Hypertension

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Chronic Liver Disease (CLD), Liver Cirrhosis, Cardiac Abnormalities, Portopulmonary Hypertension. Базовые параметры: до 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Assessment of Cardiac Problems in Children With Chronic Liver Disease

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Corrected QT (QTc) Interval [Срок оценки: Baseline (at study enrollment)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07502196 · Cardiac Problems in CLD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗