Cirrhosis and Chronic Liver DiseaseSoLiDaRityNCT07438288
Predictors of Decompensation, Acute-on-chronic Liver Failure and Mortality in Liver Cirrhosis
An observational study of Cirrhosis and Chronic Liver Disease, run by Singapore General Hospital at 3 sites in Singapore.
Trial summary
The purpose of this study is to identify factors that predict the development of decompensation, acute-on-chronic liver failure (ACLF) and death in patients with liver cirrhosis. Clinical data will be retrieved from existing hospital records. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis and Chronic Liver Disease
- What is being tested?
- Observation
- How many people
- 2,200 participants
- Where
- 3 sitesSingapore
- Study dates
- 12 Aug 2022to 12 Aug 2032
- How long will I take part?
- 10 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This multicenter study aims to recruit 2,200 cirrhotic patients over a 5 year period from 3 institutions in SingHealth - Changi General Hospital (CGH), Sengkang General Hospital (SKH) and Singapore General Hospital (SGH). Patients will be recruited both from the inpatient and outpatient setting. All consecutive patients admitted/referred to the study center with a clinical diagnosis of liver cirrhosis (based on standard clinical, radiological, elastography and/or histological criteria) will be offered inclusion into the SoLiDaRity-DAM study.
Who may be able to join
- Patients with clinical diagnosis of liver cirrhosis
- Age 18 years and above (parental consent required if below 21 years)
- Willing and able to provide informed consent
Who cannot join
- No clinical evidence of liver cirrhosis
- Not willing to provide informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore3 sites, 3 recruiting
- Recruiting
Changi General Hospital
Singapore
Rahul Kumar, MBBS, MRCP, +65 6788883, rahul.kumar@singhealth.com.sg
Rahul Kumar
- Recruiting
Sengkang General Hospital
Singapore
Marianne Anastasia De Roza, MBBS, MRCP, +65 6930500, marianne.anastasia.d.r@singhealth.com.sg
Marianne Anastasia De Roza
- Recruiting
Singapore General Hospital
Singapore
Jason Chang, MBBS, MRCP, +6321 4684, jason.chang@singhealth.com.sg
Chang Jason
About this study
Official title: Predictors of Decompensation, Acute-on-chronic Liver Failure and Mortality in Liver Cirrhosis - a Multicentre, Prospective, Observational Study From the SingHealth Chronic Liver Disease Registry (SoLiDaRity-DAM)
The purpose of this study is to identify factors that predict the development of decompensation, acute-on-chronic liver failure (ACLF) and death in patients with liver cirrhosis. Clinical data will be retrieved from existing hospital records. This information may help doctors to identify patients with cirrhosis who are at risk of deterioration earlier (before they develop complications) and to develop effective treatment strategies to prevent or delay these complications.
This study is designed as a prospective, non-interventional, observational study. This means that if you agree to participate in the study, you will not be required to undergo any additional hospital visits, tests, procedures or interventions other than the usual standard-of-care management that your doctor will provide. If you consent to participate in this study, you will be providing the study investigators permission to review and analyse your clinical data from the hospital clinical records. Your data will be collected throughout the course of your disease until liver transplantation or death.
Read the detailed description
The primary aim of this study is to prospectively identify factors that predict decompensation, ACLF and death in patients with cirrhosis.
Specific goals of the study:
- To study the 1-, 3- and 5-year risk of decompensation, ACLF and death in patients with compensated and decompensated liver cirrhosis in Singapore
- To identify clinically relevant point-in-time predictors and biomarkers for liver decompensation in general, and for specific liver-related events (including variceal bleeding, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, portal vein thrombosis, portopulmonary hypertension, hepatopulmonary syndrome, cirrhotic cardiomyopathy, hepatorenal syndrome, refractory ascites, sarcopenia, and liver cancer)
- To study the impact of underlying etiology of liver disease on the rate of decompensation, ACLF and death in liver cirrhosis
- To provide external validation of predictive scores for decompensation (ALBI, CHESS-ALARM, LSPS, PREDICT, etc).
- To serve as a core (hub) study for prospective ancillary studies regarding diagnosis, prognosis, and pathogenesis of AD and ACLF
- Conditions
- Cirrhosis and Chronic Liver Disease
- Being tested
- Observation
- Keywords
- Cirrhosis, Decompensation, Acute-on-chronic liver failure, Death
- Medical subject headings
- Fibrosis, Acute-On-Chronic Liver Failure, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Patients with liver cirrhosis will be observed to monitor for death
| Study group | Role | What they receive |
|---|---|---|
| Patients with liver cirrhosis | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Death from any cause will be recorded during the study period
Measured: Up to 10 years from date of enrollment
Secondary outcomes (1)
Decompensation of liver cirrhosis
Occurence of first episode of hepatic decompensation, defined as the development of any of the following clinical events: variceal bleeding, hepatic encephalopathy, ascites, hepatocellular carcinoma, portal vein thrombosis, sepsis and acute-on-chronic liver failure (ACLF). Diagnosis will be based on standard clinical, laboratory or imaging criteria. These data will be retrieved from hospital clinical records.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start12 Aug 2022
- Primary completion12 Aug 2027 (estimated)
- Study completion12 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis and Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- 2,200 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438288
- Sponsor's protocol ID
- 2022-2039
- Acronym
- SoLiDaRity
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data on baseline clinical characteristics and liver related outcomes
Publications
Trebicka J, Fernandez J, Papp M, Caraceni P, Laleman W, Gambino C, Giovo I, Uschner FE, Jimenez C, Mookerjee R, Gustot T, Albillos A, Banares R, Janicko M, Steib C, Reiberger T, Acevedo J, Gatti P, Bernal W, Zeuzem S, Zipprich A, Piano S, Berg T, Bruns T, Bendtsen F, Coenraad M, Merli M, Stauber R, Zoller H, Ramos JP, Sole C, Soriano G, de Gottardi A, Gronbaek H, Saliba F, Trautwein C, Ozdogan OC, Francque S, Ryder S, Nahon P, Romero-Gomez M, Van Vlierberghe H, Francoz C, Manns M, Garcia E, Tufoni M, Amoros A, Pavesi M, Sanchez C, Curto A, Pitarch C, Putignano A, Moreno E, Shawcross D, Aguilar F, Claria J, Ponzo P, Jansen C, Vitalis Z, Zaccherini G, Balogh B, Vargas V, Montagnese S, Alessandria C, Bernardi M, Gines P, Jalan R, Moreau R, Angeli P, Arroyo V; PREDICT STUDY group of the EASL-CLIF Consortium. The PREDICT study uncovers three clinical courses of acutely decompensated cirrhosis that have distinct pathophysiology. J Hepatol. 2020 Oct;73(4):842-854. doi: 10.1016/j.jhep.2020.06.013. Epub 2020 Jul 13.
PubMed 32673741
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Decompensation, Acute-on-chronic Liver Failure and Mortality in Liver Cirrhosis - a Multicentre, Prospective, Observational Study From the SingHealth Chronic Liver Disease Registry (SoLiDaRity-DAM)
- ClinicalTrials.gov ID
- NCT07438288
- Acronym / sponsor ID
- SoLiDaRity / 2022-2039
- Conditions
- Cirrhosis and Chronic Liver Disease
- Keywords
- Cirrhosis, Decompensation, Acute-on-chronic liver failure, Death
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 12 Aug 2027 (estimated)
- Study completion
- 12 Aug 2032 (estimated)
- First posted
- 27 Feb 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.
The purpose of this study is to identify factors that predict the development of decompensation, acute-on-chronic liver failure (ACLF) and death in patients with liver cirrhosis. Clinical data will be retrieved from existing hospital records. This information may help doctors to identify patients with cirrhosis who are at risk of deterioration earlier (before they develop complications) and to develop effective treatment strategies to prevent or delay these complications.
This study is designed as a prospective, non-interventional, observational study. This means that if you agree to participate in the study, you will not be required to undergo any additional hospital visits, tests, procedures or interventions other than the usual standard-of-care management that your doctor will provide. If you consent to participate in this study, you will be providing the study investigators permission to review and analyse your clinical data from the hospital clinical records. Your data will be collected throughout the course of your disease until liver transplantation or death.
Detailed description
The primary aim of this study is to prospectively identify factors that predict decompensation, ACLF and death in patients with cirrhosis.
Specific goals of the study:
- To study the 1-, 3- and 5-year risk of decompensation, ACLF and death in patients with compensated and decompensated liver cirrhosis in Singapore
- To identify clinically relevant point-in-time predictors and biomarkers for liver decompensation in general, and for specific liver-related events (including variceal bleeding, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, portal vein thrombosis, portopulmonary hypertension, hepatopulmonary syndrome, cirrhotic cardiomyopathy, hepatorenal syndrome, refractory ascites, sarcopenia, and liver cancer)
- To study the impact of underlying etiology of liver disease on the rate of decompensation, ACLF and death in liver cirrhosis
- To provide external validation of predictive scores for decompensation (ALBI, CHESS-ALARM, LSPS, PREDICT, etc).
- To serve as a core (hub) study for prospective ancillary studies regarding diagnosis, prognosis, and pathogenesis of AD and ACLF
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with liver cirrhosis | – | Other: Observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This multicenter study aims to recruit 2,200 cirrhotic patients over a 5 year period from 3 institutions in SingHealth - Changi General Hospital (CGH), Sengkang General Hospital (SKH) and Singapore General Hospital (SGH). Patients will be recruited both from the inpatient and outpatient setting. All consecutive patients admitted/referred to the study center with a clinical diagnosis of liver cirrhosis (based on standard clinical, radiological, elastography and/or histological criteria) will be offered inclusion into the SoLiDaRity-DAM study.
Key inclusion criteria (3 listed)
- Patients with clinical diagnosis of liver cirrhosis
- Age 18 years and above (parental consent required if below 21 years)
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- No clinical evidence of liver cirrhosis
- Not willing to provide informed consent
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 |
|---|---|---|
| ObservationPatients with liver cirrhosis will be observed to monitor for death | Other | Patients with liver cirrhosis |
Primary outcome
All cause mortality
Time frame: Up to 10 years from date of enrollment
Death from any cause will be recorded during the study period
1 secondary outcome
Decompensation of liver cirrhosis
Time frame: 10 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 27 Feb 2026.
- Background: PubMed 32673741Trebicka J, Fernandez J, Papp M, Caraceni P, Laleman W, Gambino C, Giovo I, Uschner FE, Jimenez C, Mookerjee R, Gustot T, Albillos A, Banares R, Janicko M, Steib C, Reiberger T, Acevedo J, Gatti P, Bernal W, Zeuzem S, Zipprich A, Piano S, Berg T, Bruns T, Bendtsen F, Coenraad M, Merli M, Stauber R, Zoller H, Ramos JP, Sole C, Soriano G, de Gottardi A, Gronbaek H, Saliba F, Trautwein C, Ozdogan OC, Francque S, Ryder S, Nahon P, Romero-Gomez M, Van Vlierberghe H, Francoz C, Manns M, Garcia E, Tufoni M, Amoros A, Pavesi M, Sanchez C, Curto A, Pitarch C, Putignano A, Moreno E, Shawcross D, Aguilar F, Claria J, Ponzo P, Jansen C, Vitalis Z, Zaccherini G, Balogh B, Vargas V, Montagnese S, Alessandria C, Bernardi M, Gines P, Jalan R, Moreau R, Angeli P, Arroyo V; PREDICT STUDY group of the EASL-CLIF Consortium. The PREDICT study uncovers three clinical courses of acutely decompensated cirrhosis that have distinct pathophysiology. J Hepatol. 2020 Oct;73(4):842-854. doi: 10.1016/j.jhep.2020.06.013. Epub 2020 Jul 13.
- Individual participant dataSharing planned: Yes. Anonymized data on baseline clinical characteristics and liver related outcomes
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Chronic Liver Disease, run by Singapore General Hospital at 3 sites in Singapore.
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 2 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Jason Pik Eu Chang, MBBS, MRCP (+65 6321 4684, jason.chang@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: Up to 10 years from date of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07438288, which also lists 1 linked publication.
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 27 Feb 2026.