Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
Qualifiers
Aged 18 years of above
Established diagnosis of chronic liver disease(s) of the following etiologies
Alcohol-related liver disease (ARLD)
Chronic hepatitis B (CHB)
Disqualifiers
Presence of high-risk varices (HRV) (i.e. moderate to large oesophageal varices [OV] or OV with red wale sign) found in OGD
Current use of non-selective beta-blocker (NSBB) or any use of NSBB within 6 months before
Use of selective beta blocker, such as atenolol or metoprolol, is not excluded
Selective beta-blocker will be switched to carvedilol in NSBB arm, and will be kept unchanged in conventional arm if there is clinical need for the selective beta-blocker
Trial design
Treatments tested in this trial
- Carvedilol
Treatment groups
474 Participants
are divided into 2 treatment groupsSponsors and collaborators
Chinese University of Hong Kong
Lead sponsor
Singapore General Hospital
Collaborator
University of Palermo
Collaborator
University of Malaya
Collaborator
Shanghai Jiao Tong University School of Medicine
Collaborator
Royal Prince Alfred Hospital, Sydney, Australia
Collaborator
Source ClinicalTrials.gov