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RECRUITING

NCT06449339

PHASE4

Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

474

Start Date

2024-07-17

Completion Date

2031-07-30

Last Updated

2025-06-22

Healthy Volunteers

Conditions

Portal Hypertension Hepatic Decompensation Advanced Chronic Liver Disease

Interventions

DRUG

Carvedilol

Patients in the NSBB arm will receive generic carvedilol. The starting dose of oral carvedilol is 6.25mg daily (to be taken once or twice per day) and can be adjusted at each scheduled visit (either by increasing the dosage or frequency of dose administration) according to patients' tolerance, as well as the blood pressure and pulse rate that the systolic blood pressure should be not lower than 90 mmHg and pulse rate not lower than 55 beats per minute. The dosage of carvedilol can also be titrated or discontinued at unscheduled visit according to patient's condition. In case carvedilol is discontinued, it can be resumed from the starting dose at next scheduled visit if there is no contraindication for carvedilol. The dose of carvedilol will be kept at 6.25-12.5mg per day unless there are additional non-hepatic indications such as arterial hypertension or cardiac disease warranting higher carvedilol dosage. The maximum allowed dose of carvedilol is 50mg daily as per drug instruction.

Inclusion Criteria: * 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) * Chronic hepatitis C (CHC) * Metabolic dysfunction-associated steatotic liver disease (MASLD) § Non-obese (BMI \<30kg/m2) and obese (BMI ≥30 kg/m2) * In high-risk grey zone or CSPH, by Baveno VII criteria (for ARLD, CHB, CHC and non-obese MASLD) or ANTICIPATE-NASH model (for obese MASLD) within 6 months from screening * Baveno VII criteria (for ARLD, CHB, CHC and non-obese MASLD) * LSM ≥25 kPa (CSPH) * LSM ≥20 kPa - \<25 kPa and platelet count \<150 x 10\^9/L; or LSM ≥15 kPa - \<20 kPa and platelet count \<110 x 10\^9/L (high-risk grey zone) * ANTICIPATE-NASH model (for obese MASLD) * Predictive probability for CSPH \>90% (CSPH) * Predictive probability for CSPH ≥60% - \<90% (high-risk grey zone) Exclusion Criteria: * 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 * Contraindication to NSBB (e.g. Type II/III heart block or baseline bradycardia \<60/minute, hypotension with systolic blood pressure (SBP) \<100 mmHg, asthma, poorly controlled chronic obstructive pulmonary disease, and peripheral vascular disease) * Current use of nitrated drugs or any use of nitrated drugs within 6 months before o Use of sublingual nitrate, such as glyceryl trinitrate, is not excluded * Contraindication to OGD (e.g. Intestinal perforation or obstruction) * Current or history of decompensated liver cirrhosis (i.e. Child's C cirrhosis, prior decompensating events such as ascites, variceal bleeding, hepatic encephalopathy and hepatorenal syndrome) o Child's B cirrhosis without decompensating events is not excluded * Current or history of hepatocellular carcinoma (HCC) * Current or history of portal vein thrombosis * Transjugular intrahepatic portosystemic shunt (TIPS) * Liver transplantation * Serious medical illness with limited life expectancy of less than 6 months * Pregnancy * Unable to obtain or refusal of informed consent from patient

Locations (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong