Compensated Advanced Chronic Liver DiseaseNCT07534046
Impact of Metabolic Disorders on cACLD Outcomes
An observational study of Compensated Advanced Chronic Liver Disease, run by The Second Affiliated Hospital of Chongqing Medical University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Compensated Advanced Chronic Liver Disease
- What is being tested?
- Observational Study
- How many people
- 4,307 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2031
- How long will I take part?
- 5 Years
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll approximately 4,307 adults with compensated advanced chronic liver disease (cACLD) from six major medical centers across China. Eligible participants are males and females aged 18-75 years with: (1) imaging evidence of cirrhosis; (2) pathological findings of F3/4 fibrosis; or (3) liver stiffness measurement ≥10 kPa by VCTE. Patients are excluded if they have prior decompensation events (variceal bleeding, moderate-severe ascites, overt hepatic encephalopathy), hepatocellular carcinoma/other malignancies with life expectancy <1 year, prior liver transplantation, severe organ dysfunction, or are pregnant/breastfeeding. All participants provide written informed consent and undergo regular follow-up every 3-6 months for up to 5 years. No study-specified interventions are administered; participants receive standard medical care as determined by their physicians.
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
About this study
Official title: Impact of Metabolic Disorders on Clinical Outcomes in Patients With Compensated Advanced Chronic Liver Disease: A Multicenter, Prospective, Cohort Study
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.
- Being tested
- Observational Study
- Keywords
- MRE, cACLD, metabolic disorders
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of liver-related adverse events.
Decompensation: clinically significant ascites, esophageal-gastric variceal bleeding, overt hepatic encephalopathy; Liver failure; Hepatocellular carcinoma.
Measured: 5 years
Secondary outcomes (3)
Liver-related death
Measured: 5 years
Non-liver-related clinical events
Cardiovascular and cerebrovascular events, extrahepatic organ failure, extrahepatic malignancies, new-onset diabetes mellitus, fractures, chronic kidney disease
Measured: 5 years
All-cause death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compensated Advanced Chronic Liver DiseaseStudies of the same condition, open and under way.
- 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
- 4,307 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534046
- Sponsor's protocol ID
- 2026-IIT-SL-018
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Metabolic Disorders on Clinical Outcomes in Patients With Compensated Advanced Chronic Liver Disease: A Multicenter, Prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT07534046
- Acronym / sponsor ID
- 2026-IIT-SL-018
- Keywords
- MRE, cACLD, metabolic disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,307 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 16 Apr 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll approximately 4,307 adults with compensated advanced chronic liver disease (cACLD) from six major medical centers across China. Eligible participants are males and females aged 18-75 years with: (1) imaging evidence of cirrhosis; (2) pathological findings of F3/4 fibrosis; or (3) liver stiffness measurement ≥10 kPa by VCTE. Patients are excluded if they have prior decompensation events (variceal bleeding, moderate-severe ascites, overt hepatic encephalopathy), hepatocellular carcinoma/other malignancies with life expectancy <1 year, prior liver transplantation, severe organ dysfunction, or are pregnant/breastfeeding. All participants provide written informed consent and undergo regular follow-up every 3-6 months for up to 5 years. No study-specified interventions are administered; participants receive standard medical care as determined by their physicians.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (11 listed)
- 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:
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 |
|---|---|---|
| Observational StudyThis 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. | Other | – |
Primary outcome
Occurrence of liver-related adverse events.
Time frame: 5 years
Decompensation: clinically significant ascites, esophageal-gastric variceal bleeding, overt hepatic encephalopathy; Liver failure; Hepatocellular carcinoma.
3 secondary outcomes
Liver-related death
Time frame: 5 years
Non-liver-related clinical events
Time frame: 5 years
All-cause death
Time frame: 5 years
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 16 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 Compensated Advanced Chronic Liver Disease, run by The Second Affiliated Hospital of Chongqing Medical 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 3 inclusion and 11 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 16 Apr 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?
Occurrence of liver-related adverse events. (time frame: 5 years). 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 16 Apr 2026.