Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449339
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-05-29
Brief Title:
Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Baveno VII Criteria-guided Initiation of Non-selective Beta Blocker in Patients With Compensated Advanced Chronic Liver Disease to Reduce Hepatic Decompensation an Open-label Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BB_cACLD
Brief Summary:
The goal of this randomised controlled trial is to evaluate the effect of carvedilol a non-selective beta-blocker in patients with compensated advanced chronic liver disease under clinically significant portal hypertension or the grey zone of Baveno VII criteria
The main question it aims to answer is
Does carvedilol reduce hepatic decompensation and mortality in these patients despite the absence of varices needing treatment
Researchers will compare carvedilol to no carvedilol to see if carvedilol can prevent hepatic decompensation and mortality
Participants will either take carvedilol or not taking carvedilol for 5 years with regular clinic visit for checkups and investigations including blood tests ultrasonography of the liver upper gastrointestinal endoscopy transient elastography
The main question it aims to answer is
Does carvedilol reduce hepatic decompensation and mortality in these patients despite the absence of varices needing treatment
Researchers will compare carvedilol to no carvedilol to see if carvedilol can prevent hepatic decompensation and mortality
Participants will either take carvedilol or not taking carvedilol for 5 years with regular clinic visit for checkups and investigations including blood tests ultrasonography of the liver upper gastrointestinal endoscopy transient elastography
Detailed Description:
The study is a multi-centre open-label randomised controlled trial conducted in Prince of Wales Hospital a tertiary academic hospital in Hong Kong as well as other international study sites Eligible patients will be randomised to NSBB arm ie receiving carvedilol or conventional arm ie not receiving carvedilol aiming to test the hypothesis that Baveno VII criteria-guided carvedilol treatment in compensated advanced chronic liver disease cACLD patients in grey zone or with clinically significant portal hypertension CSPH is superior to not treating them in the absence of high-risk varices HRV in terms of prevention of first occurrence of hepatic decompensation and mortality Consecutive patients in the participating study sites with cACLD fulfilling the high-risk grey zone and CSPH criteria by LSM and platelet count will be invited to this study The patients will undergo oesophagogastroduodenoscopy OGD for screening of oesophageal varices OV Those without HRV will be randomised into NSBB and conventional arms Patients in the NSBB arm will be started on carvedilol Those in the conventional arm will not receive NSBB as per current standard of practice The expected accrual duration is 24 months with an interim analysis to be performed when all enrolled patients have reached 1 year of follow-up or the primary endpoint The total follow-up duration is 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None