Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors

NCT06549673 | Recruiting

• 1 other identifier: Stop-NSBB
• Study Type: observational
• Target: 375
• Locations: 5 countries
• Sites: 8

Brief Summary

This multicentre, prospective cohort study aims to enrol 375 patients with cirrhosis who meet the following criteria:

1. 1.effective management or elimination of the primary aetiological factor (i.e., sustained virological response in chronic hepatitis C, complete viral suppression in chronic hepatitis B, or long-term alcohol abstinence in alcohol-related liver disease),
2. 2.liver stiffness measurements under 25 kPa, and
3. 3.absence of varices as confirmed by endoscopy

Conditions

Portal Hypertension; Cirrhosis; Varices, Esophageal

Keywords

Portal hypertension; Cirrhosis; Esophageal varices; Gastric varices

Outcome Measures

Primary Outcomes (1)

• Recurrent varices

  Upper endoscopy will be repeated to detect recurrent varices after stopping non-selective beta-blockers

  1 year

Secondary Outcomes (3)

• Prevalence of varices in screening cohort

  Baseline

• Resumption of NSBB and variceal haemorrhage

  5 years

• Other decompensating events

  5 years

Study Arms (1)

Patients with cirrhosis

The patient cohort will have the primary aetiological factor of liver disease controlled, low liver stiffness measurement of below 25 kPa by vibration-controlled transient elastography, and the absence of high-risk varices on upper gastrointestinal endoscopy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be identified from the general medical and hepatology clinics in Hong Kong and collaborating countries.

You may qualify if:

• Aged 18 years or above
• Evidence of cirrhosis, based on either radiological and/or clinical features
• History of varices, variceal haemorrhage or portal hypertension warranting NSBB
• Removal or suppression of the primary aetiological factor (i.e., sustained virological response in chronic hepatitis C, complete hepatitis B virus DNA suppression in chronic hepatitis B, and long-term alcohol abstinence in alcohol-related liver disease)
• LSM \<25 kPa
• Provision of written informed consent

You may not qualify if:

• Current or history of hepatocellular carcinoma.
• Radiological evidence of portal vein thrombosis.
• History of other malignancies (unless in complete remission for \>5 years).
• History of liver transplantation or liver resection.
• Contraindications to undergoing endoscopy.
• Other clinical indications for NSBB (e.g., cardiovascular disease, arterial hypertension)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Southern Medical University, China: collaborator
• Ruijin Hospital North Shanghai Jiao Tong University School of Medicine: collaborator
• National University Hospital, Singapore: collaborator
• Changi General Hospital: collaborator
• Institute of Liver and Biliary Sciences, India: collaborator
• Royal Prince Alfred Hospital, Sydney, Australia: collaborator
• Asian Institute of Gastroenterology, India: collaborator

Study Sites (8)

Royal Prince Alfred Hospital

Sydney, Australia

NOT YET RECRUITING

Southern Medical University

Guangzhou, China

NOT YET RECRUITING

Ruijing Hospital

Shanghai, China

NOT YET RECRUITING

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

AIG Hospital

Hyderabad, India

NOT YET RECRUITING

Institute of Liver and Biliary Sciences

New Delhi, India

NOT YET RECRUITING

Changi General Hospital

Singapore, Singapore

NOT YET RECRUITING

National University Hospital, Singapore

Singapore, Singapore

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Store 10 mL of clotted blood and 10 mL of EDTA blood for future genetic and biochemical research (with separate consent)

MeSH Terms

Conditions

Hypertension, Portal; Fibrosis; Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Vincent Wong, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Wong, MD

CONTACT

85235051299; wongv@cuhk.edu.hk

Angel Chim, MSc

CONTACT

85235054205; angelchim@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2031
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after the first publication until 15 years after the end of the study
• Access Criteria: By email communication

Locations

IN (2); SG (2); CN (2); HK (1); AU (1)