Effect of Non-Selective Beta-Blockers on Outcomes in Cirrhosis Patients After Hospitalization: A Retrospective Cohort Using Target Trial Design

Samsung Medical Center

Status: Active, not recruiting

Conditions: Decompensated Cirrhosis of Liver; Cirrhosis

Treatments: Drug: Non-selective beta-blockers

Study type: Observational

Funder types: Other

Identifiers

NCT06977685

SamsungMC_LC_NSBB_2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,725 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

7,725 participants in 2 patient groups

With NSBB

Description:

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.

Treatment:

Drug: Non-selective beta-blockers

Without NSBB

Description:

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.