CirrhosisNCT06977685
Effect of Non-Selective Beta-Blockers on Outcomes in Cirrhosis Patients After Hospitalization: A Retrospective Cohort Using Target Trial Design
An observational study of Cirrhosis and Decompensated Cirrhosis of Liver, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The goal of this observational study is to learn if non-selective beta-blockers (NSBB) improve outcomes in patients with chronic hepatitis B or C who are discharged after hospitalization for acute decompensation of cirrhosis. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cirrhosis, Decompensated Cirrhosis of Liver
- What is being tested?
- Non-selective beta-blockers
- How many people
- 7,725 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2013to 31 Dec 2025
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include adult patients with liver cirrhosis and chronic hepatitis B or C who were hospitalized due to hepatic complications in South Korea between January 2013 and October 2023. The study will focus on patients who experienced hepatic complications including ascites, peritonitis, hepatorenal syndrome, and hepatic encephalopathy. Both patients who received NSBB at discharge and those who did not will be included in the analysis to allow for comparison between these groups.
Who may be able to join
- Patients with liver cirrhosis and chronic hepatitis B or C
- Hospitalized due to hepatic complications (hepatic encephalopathy, hepatorenal syndrome, ascites, or spontaneous peritonitis) between January 2013 and October 2023
- Age 19 years and older
Who cannot join
- History of bradycardia
- History of hypotension
- History of asthma
- History of cancer
- History of heart failure
- History of myocardial infarction
Show all 11Show fewer
- History of stroke
- History of chronic kidney disease
- History of chronic obstructive pulmonary disease (COPD)
- History of ischemic heart disease
- Esophageal variceal bleeding during index hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Non-Selective Beta-Blockers on Outcomes in Patients Discharged After Hospitalization for Acute Decompensation of Cirrhosis: A Retrospective Cohort Study Using Target Trial Emulation Design
The goal of this observational study is to learn if non-selective beta-blockers (NSBB) improve outcomes in patients with chronic hepatitis B or C who are discharged after hospitalization for acute decompensation of cirrhosis. The main questions it aims to answer are:
- Does NSBB use at discharge reduce mortality rates in cirrhotic patients with hepatic complications?
- Does NSBB use at discharge decrease hospital readmission rates?
Read more
Researchers will compare patients discharged with NSBB prescriptions to those without NSBB to see if NSBB use decreases mortality and readmission rates.
Participants were patients hospitalized for hepatic complications (hepatic encephalopathy, hepatorenal syndrome, ascites, or spontaneous peritonitis) between January 2013 and October 2023, with data analyzed retrospectively using a target trial emulation design.
Read the detailed description
This retrospective cohort study aims to investigate the effects of non-selective beta-blockers (NSBB) on clinical outcomes in patients with chronic hepatitis B or C who were hospitalized for acute decompensation of cirrhosis. The study employs a target trial emulation design to simulate a randomized controlled trial using observational data.
Background and Rationale:
Non-selective beta-blockers are commonly used in patients with cirrhosis to reduce portal pressure and prevent complications. However, their role in patients discharged after hospitalization for hepatic complications remains unclear.
Study Design:
The study uses national health insurance claims data from South Korea to identify eligible patients and their outcomes. To address potential confounding inherent in observational studies, three analytical approaches are employed:
- Traditional multivariable regression analysis
- Propensity score matching
- Inverse probability of treatment weighting (IPTW)
Treatment Definition:
NSBB use is defined as a prescription for at least 2 days at discharge. Two types of NSBB are examined: propranolol and carvedilol. Dosage effects are also explored by categorizing NSBB use into low-dose and middle-high dose groups.
Endpoints:
The primary endpoint is all-cause mortality, while secondary endpoints include all-cause hospital readmission and hepatic complication-related hospital readmission. All endpoints are assessed at 1 month, 3 months, 6 months, and 1 year after discharge.
Statistical Analysis:
Kaplan-Meier survival analyses and Cox proportional hazards models will be used to compare outcomes between treatment groups. Models will be adjusted for demographic factors, comorbidities, concurrent medications, health behaviors, and admission-related variables. Subgroup analyses will be conducted based on age, sex, and type of hepatic complication.
This study aims to provide clinicians with evidence regarding the use of NSBB in patients with viral hepatitis-related cirrhosis following hospitalization for acute decompensation, potentially informing clinical decision-making for this high-risk population.
- Conditions
- Cirrhosis, Decompensated Cirrhosis of Liver
- Being tested
- Non-selective beta-blockers
- Keywords
- Non-Selective Beta-Blockers, Decompensated Cirrhosis, Target Trial Emulation
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-selective beta-blockersDrug
Also called Carvedilol, Propranolol
Non-selective beta-blockers (NSBB) prescribed at discharge for patients hospitalized with hepatic complications. The study will analyze two types of NSBB: propranolol and carvedilol. The study will also examine potential dosage effects by categorizing NSBB use into low-dose and middle-high dose groups. NSBB use is defined as a prescription for at least 2 days at discharge.
| Study group | Role | What they receive |
|---|---|---|
| With NSBB | Patients with chronic hepatitis B or C who were hospitalized for hepatic complications (hepatic encephalopathy, hepatorenal syndrome, ascites, or spontaneous peritonitis) and received NSBB prescription at discharge. The study will compare outcomes in this group with the non-NSBB group. Receives: Drug: Non-selective beta-blockers | |
| Without NSBB | Patients with chronic hepatitis B or C who were hospitalized for hepatic complications (hepatic encephalopathy, hepatorenal syndrome, ascites, or spontaneous peritonitis) and did not receive NSBB prescription at discharge. This group will serve as the control group for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Death from any cause following discharge after hospitalization for hepatic complications of cirrhosis. Mortality data will be obtained through death registry linkage. Hazard ratios (HR) will be calculated using Cox proportional hazards models, adjusted for demographic factors, comorbidities, medications at discharge, health behaviors, and admission-related variables.
Measured: 1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization
Secondary outcomes (2)
All-cause hospital readmission
Any hospital readmission following discharge after the index hospitalization for hepatic complications of cirrhosis. Readmission data will be obtained from hospitalization claims. Hazard ratios (HR) will be calculated using Cox proportional hazards models, adjusted for demographic factors, comorbidities, medications at discharge, health behaviors, and admission-related variables.
Measured: 1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization
Hepatic complication-related hospital readmission
Hospital readmission specifically related to hepatic complications (hepatic encephalopathy, hepatorenal syndrome, ascites, or spontaneous peritonitis) following discharge after the index hospitalization. Readmission data will be categorized based on diagnosis codes in hospitalization claims. The same statistical methods as for all-cause readmission will be applied.
Measured: 1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jan 2013
- Primary completion31 Oct 2023
- Study completion31 Dec 2025 (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 CirrhosisStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Retrospective
- Enrolment
- 7,725 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dong Hyun Sinn, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977685
- Sponsor's protocol ID
- SamsungMC_LC_NSBB_2025
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the sensitive nature of the medical information and patient privacy concerns.
Publications
Song BG, Lee M, Kang D, Kang W, Shim JH, Sinn DH, Gwak GY. Non-Selective Beta-Blocker Use Is Associated With Lower Mortality After Decompensation in Cirrhosis: A Nationwide Target Trial Emulation. Aliment Pharmacol Ther. 2026 Jun 22. doi: 10.1111/apt.70807. Online ahead of print.
PubMed 42328960
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Selective Beta-Blockers on Outcomes in Patients Discharged After Hospitalization for Acute Decompensation of Cirrhosis: A Retrospective Cohort Study Using Target Trial Emulation Design
- ClinicalTrials.gov ID
- NCT06977685
- Acronym / sponsor ID
- SamsungMC_LC_NSBB_2025
- Conditions
- Cirrhosis, Decompensated Cirrhosis of Liver
- Keywords
- Non-Selective Beta-Blockers, Decompensated Cirrhosis, Target Trial Emulation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,725 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 May 2025 (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 goal of this observational study is to learn if non-selective beta-blockers (NSBB) improve outcomes in patients with chronic hepatitis B or C who are discharged after hospitalization for acute decompensation of cirrhosis. The main questions it aims to answer are:
- Does NSBB use at discharge reduce mortality rates in cirrhotic patients with hepatic complications?
- Does NSBB use at discharge decrease hospital readmission rates?
Researchers will compare patients discharged with NSBB prescriptions to those without NSBB to see if NSBB use decreases mortality and readmission rates.
Participants were patients hospitalized for hepatic complications (hepatic encephalopathy, hepatorenal syndrome, ascites, or spontaneous peritonitis) between January 2013 and October 2023, with data analyzed retrospectively using a target trial emulation design.
Detailed description
This retrospective cohort study aims to investigate the effects of non-selective beta-blockers (NSBB) on clinical outcomes in patients with chronic hepatitis B or C who were hospitalized for acute decompensation of cirrhosis. The study employs a target trial emulation design to simulate a randomized controlled trial using observational data.
Background and Rationale:
Non-selective beta-blockers are commonly used in patients with cirrhosis to reduce portal pressure and prevent complications. However, their role in patients discharged after hospitalization for hepatic complications remains unclear.
Study Design:
The study uses national health insurance claims data from South Korea to identify eligible patients and their outcomes. To address potential confounding inherent in observational studies, three analytical approaches are employed:
- Traditional multivariable regression analysis
- Propensity score matching
- Inverse probability of treatment weighting (IPTW)
Treatment Definition:
NSBB use is defined as a prescription for at least 2 days at discharge. Two types of NSBB are examined: propranolol and carvedilol. Dosage effects are also explored by categorizing NSBB use into low-dose and middle-high dose groups.
Endpoints:
The primary endpoint is all-cause mortality, while secondary endpoints include all-cause hospital readmission and hepatic complication-related hospital readmission. All endpoints are assessed at 1 month, 3 months, 6 months, and 1 year after discharge.
Statistical Analysis:
Kaplan-Meier survival analyses and Cox proportional hazards models will be used to compare outcomes between treatment groups. Models will be adjusted for demographic factors, comorbidities, concurrent medications, health behaviors, and admission-related variables. Subgroup analyses will be conducted based on age, sex, and type of hepatic complication.
This study aims to provide clinicians with evidence regarding the use of NSBB in patients with viral hepatitis-related cirrhosis following hospitalization for acute decompensation, potentially informing clinical decision-making for this high-risk population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With NSBB | – | Drug: Non-selective beta-blockersPatients with chronic hepatitis B or C who were hospitalized for hepatic complications (hepatic encephalopathy, hepatorenal syndrome, ascites, or spontaneous peritonitis) and received NSBB prescription at discharge. The study will compare outcomes in this group with the non-NSBB group. |
| Without NSBB | – | –Patients with chronic hepatitis B or C who were hospitalized for hepatic complications (hepatic encephalopathy, hepatorenal syndrome, ascites, or spontaneous peritonitis) and did not receive NSBB prescription at discharge. This group will serve as the control group for comparison. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult patients with liver cirrhosis and chronic hepatitis B or C who were hospitalized due to hepatic complications in South Korea between January 2013 and October 2023. The study will focus on patients who experienced hepatic complications including ascites, peritonitis, hepatorenal syndrome, and hepatic encephalopathy. Both patients who received NSBB at discharge and those who did not will be included in the analysis to allow for comparison between these groups.
Key inclusion criteria (3 listed)
- Patients with liver cirrhosis and chronic hepatitis B or C
- Hospitalized due to hepatic complications (hepatic encephalopathy, hepatorenal syndrome, ascites, or spontaneous peritonitis) between January 2013 and October 2023
- Age 19 years and older
Key exclusion criteria (11 listed)
- History of bradycardia
- History of hypotension
- History of asthma
- History of cancer
- History of heart failure
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 |
|---|---|---|
| Non-selective beta-blockersAlso: Carvedilol, PropranololNon-selective beta-blockers (NSBB) prescribed at discharge for patients hospitalized with hepatic complications. The study will analyze two types of NSBB: propranolol and carvedilol. The study will also examine potential dosage effects by categorizing NSBB use into low-dose and middle-high dose groups. NSBB use is defined as a prescription for at least 2 days at discharge. | Drug | With NSBB |
Primary outcome
All-cause mortality
Time frame: 1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization
Death from any cause following discharge after hospitalization for hepatic complications of cirrhosis. Mortality data will be obtained through death registry linkage. Hazard ratios (HR) will be calculated using Cox proportional hazards models, adjusted for demographic factors, comorbidities, medications at discharge, health behaviors, and admission-related variables.
2 secondary outcomes
All-cause hospital readmission
Time frame: 1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization
Hepatic complication-related hospital readmission
Time frame: 1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization
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 18 May 2025.
- Derived from this study: PubMed 42328960Song BG, Lee M, Kang D, Kang W, Shim JH, Sinn DH, Gwak GY. Non-Selective Beta-Blocker Use Is Associated With Lower Mortality After Decompensation in Cirrhosis: A Nationwide Target Trial Emulation. Aliment Pharmacol Ther. 2026 Jun 22. doi: 10.1111/apt.70807. Online ahead of print.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the sensitive nature of the medical information and patient privacy concerns.
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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. This study is not recruiting at the moment.
Dong Hyun Sinn, MD, PhD principal investigator
Samsung Medical Center
1 site 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 Decompensated Cirrhosis of Liver, run by Samsung Medical Center at 1 site in South Korea.
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: under way, not looking for participants, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
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?
All-cause mortality (time frame: 1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization). 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 NCT06977685, 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 18 May 2025.