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

NCT06977685 · tracked via the Priya Life Science South Korea tracker

Sponsor

Samsung Medical Center

Phase

Observational

Started

2013-01-01

Last updated

2025-05-18

Condition(s) studied

CirrhosisDecompensated Cirrhosis of Liver

Investigational drug(s) / intervention(s)

Non-selective beta-blockers →

Non-selective beta-blockers: 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 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.

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

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

Primary outcome measure(s)

All-cause mortality — 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.

Trial sites (1)

Facility	City	Region	Status
Samsung Medical Center	Seoul	South Korea

More Samsung Medical Center trials in South Korea

IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI Recruiting

Genomic Profiling of Pancreatic Cystic Tumors Starting soon

Head and Neck Cancer Omics/Integrated Precision Medicine (HOPE) Recruiting

Korean Stroke Cohort for Functioning and Rehabilitation-II Active, not recruiting

Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06977685 on ClinicalTrials.gov ↗ ← All trials in South Korea