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

NCT06977685 | Active Not Recruiting

• 1 other identifier: SamsungMC_LC_NSBB_2025
• Study Type: observational
• Target: 7,725
• Locations: 1 country
• Sites: 1

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. 1.Does NSBB use at discharge reduce mortality rates in cirrhotic patients with hepatic complications?
2. 2.Does NSBB use at discharge decrease hospital readmission rates?

Conditions

Cirrhosis; Decompensated Cirrhosis of Liver

Keywords

Non-Selective Beta-Blockers; Decompensated Cirrhosis; Target Trial Emulation

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization

Secondary Outcomes (2)

• All-cause hospital readmission

  1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization

• Hepatic complication-related hospital readmission

  1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization

Study Arms (2)

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.

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.

Interventions

Non-selective beta-blockers DRUG

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.

Also known as: Carvedilol, Propranolol

With NSBB

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Carvedilol; Propranolol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Phenoxypropanolamines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Dong Hyun Sinn, MD, PhD

  Samsung Medical Center, Sungkyunkwan University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 18, 2025
• Study Start: January 1, 2013
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)