Clinical trial NCT06977685: Effect of Non-Selective Beta-Blockers on Outcomes in Cirrhosis Patients After Hospitalization: A Retrospective Cohort Using Target Trial Design
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cirrhosis
Decompensated Cirrhosis of Liver
Keywords: Non-Selective Beta-Blockers
Decompensated Cirrhosis
Target Trial Emulation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 7725
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. Does NSBB use at discharge reduce mortality rates in cirrhotic patients with hepatic complications?
2. 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:

1. Traditional multivariable regression analysis
2. Propensity score matching
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* History of bradycardia
* History of hypotension
* History of asthma
* History of cancer
* History of heart failure
* History of myocardial infarction
* 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

Primary outcomes:
measure: All-cause mortality
timeFrame: 1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization
Secondary outcomes:
measure: All-cause hospital readmission
timeFrame: 1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization
measure: Hepatic complication-related hospital readmission
timeFrame: 1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Dong Hyun Sinn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: