Impact of Metabolic Disorders on cACLD Outcomes

Официальное название

Impact of Metabolic Disorders on Clinical Outcomes in Patients With Compensated Advanced Chronic Liver Disease: A Multicenter, Prospective, Cohort Study

Обзор

This multicenter, prospective, cohort study is designed to investigate how metabolic disorders (such as obesity, diabetes, and high cholesterol) influence the progression of liver disease in patients with compensated advanced chronic liver disease (cACLD). Chronic liver disease often progresses silently for many years before serious complications like liver failure, cancer, or variceal bleeding develop. While it is known that metabolic problems can accelerate liver damage, current tools for predicting individual risk remain limited. This study aims to enroll approximately 4,307 adults with cACLD from six major medical centers across China. Participants will undergo regular follow-up every 3 to 6 months for up to 5 years, during which routine clinical assessments, non-invasive imaging (including MRI elastography), metabolic health indicators, and biological samples will be collected. No experimental treatments are provided; participants receive standard medical care as determined by their physicians. The primary goal is to determine whether metabolic abnormalities are linked to serious liver-related events including ascites, variceal bleeding, hepatic encephalopathy, liver cancer, liver failure, and liver-related death. The study will also evaluate how advanced imaging techniques predict these complications and develop a comprehensive risk prediction model integrating metabolic factors, imaging results, and traditional liver function tests. By better understanding the role of metabolic health in liver disease progression, this research may help identify new intervention targets and improve the ability to predict which patients are most likely to develop serious complications, ultimately leading to more personalized care and better outcomes for individuals with chronic liver disease.

Вмешательства

• Другое Observational Study
  This is a multicenter, prospective, observational cohort study. No study-specific interventions are administered. Participants receive standard medical care as determined by their treating physicians according to routine clinical practice. All examinations, including imaging and laboratory tests, are performed as part of standard care or for observational research purposes only, without assignment to a specific treatment arm.

Первичные конечные точки

• Occurrence of liver-related adverse events. [Срок оценки: 5 years]

Вторичные конечные точки (3)

• Liver-related death [Срок оценки: 5 years]
• Non-liver-related clinical events [Срок оценки: 5 years]
• All-cause death [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Voluntary signing of written informed consent;
• Aged between 18 and 75 years (inclusive of 18 and 75), both genders eligible;
• Evidence of liver cirrhosis by imaging (including ultrasonography, CT, MRI), or pathological findings indicating F3/4 fibrosis, or Liver Stiffness Measurement (LSM) ≥10 kPa as measured by VCTE;

Критерии исключения

• Decompensated cirrhosis at baseline, defined as having experienced any of the following three conditions within the past year: ① History of variceal bleeding; ② Moderate to severe ascites; ③ Overt hepatic encephalopathy;
• Prior or current diagnosis of hepatocellular carcinoma or other malignancies that cannot be treated with curative intent, with an expected survival of less than 1 year;
• Previous orthotopic liver transplantation;
• Concurrent hematological and lymphatic system diseases;
• Concurrent severe dysfunction of vital organs such as the heart, lungs, brain, and kidneys:

History of pulmonary diseases: Severe pulmonary diseases that significantly affect lung function, such as severe emphysema, pulmonary embolism;

History of severe heart disease, meeting one of the following criteria:

• Decompensated cardiac insufficiency (New York Heart Association \[NYHA\] Class III-IV);
• Unstable angina pectoris; Chronic Kidney Disease (CKD) stage ≥3 (defined as baseline serum creatinine exceeding 177 μmol/L);

• Pregnant or breastfeeding women;
• Judged by the investigator to be unsuitable for participation in this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07534046 · 2026-IIT-SL-018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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