RecruitingNCT06549673

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

Assessing the Safety of Discontinuing Non-selective Beta-blockers in Cirrhotic Patients With Managed Primary Aetiological Factors According to Baveno VII Consensus


Sponsor

Chinese University of Hong Kong

Enrollment

375 participants

Start Date

Jan 20, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This multicentre, prospective cohort study aims to enrol 375 patients with cirrhosis who meet the following criteria: 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. liver stiffness measurements under 25 kPa, and 3. absence of varices as confirmed by endoscopy Following the cessation of non-selective beta-blockers, patients will undergo a follow-up endoscopy at the one-year mark. The study's primary endpoint is recurrent varices in 1 year. Success will be defined as the upper bound of the 95% confidence interval for recurrent varices being \<5%. Should this criterion be met, the study will extend to predefined analyses of variceal haemorrhage and hepatic decompensation at 3-and 10-year intervals (funded through local resources; the General Research Fund will cover patient recruitment costs for 1 year). Clinical assessments, laboratory tests, liver and spleen stiffness measurements will be performed at baseline, 3 months, 6 months and 12 months to identify potential predictors of variceal recurrence and assess the feasibility of early identification.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether it is safe to stop taking non-selective beta-blockers (NSBBs) — a type of blood pressure/heart rate medication often prescribed to prevent dangerous bleeding from enlarged blood vessels in the esophagus (varices) — in patients with cirrhosis (liver scarring) whose underlying liver disease has been successfully treated or suppressed. As the liver disease improves, some patients may no longer need these medications. **You may be eligible if...** - You are 18 years of age or older - You have cirrhosis confirmed by imaging or clinical signs - You have a history of varices, variceal bleeding, or high blood pressure in the portal vein that led to being prescribed beta-blockers - Your underlying liver disease cause has been eliminated or suppressed (e.g., cured hepatitis C, hepatitis B well-controlled on treatment, or long-term alcohol abstinence) - Your liver stiffness measurement is below 25 kPa **You may NOT be eligible if...** - Your liver disease is still active or untreated - You have autoimmune or hereditary liver disease - Your liver function is severely impaired - You have significant medical reasons to continue beta-blockers (e.g., heart conditions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(8)

Royal Prince Alfred Hospital

Sydney, Australia

Southern Medical University

Guangzhou, China

Ruijing Hospital

Shanghai, China

Prince of Wales Hospital

Hong Kong, Hong Kong

AIG Hospital

Hyderabad, India

Institute of Liver and Biliary Sciences

New Delhi, India

Changi General Hospital

Singapore, Singapore

National University Hospital, Singapore

Singapore, Singapore

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NCT06549673


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