Health TrialsbyHealthPanel

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

ConditionsPortal HypertensionHepatic DecompensationAdvanced 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Carvedilol

    Drug

    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.

Treatment groups

474 Participants
are divided into 2 treatment groups
Group A: non-selective beta-blocker (NSBB)Experimental treatment 1 intervention
Group B: ConventionalNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

composite of incident high-risk varices (HRV), hepatic decompensation or death

HRV is defined by moderate to large oesophageal varices (OV) or OV with red wale sign. Hepatic decompensation is defined by the presence of ascites, variceal bleeding or overt hepatic encephalopathy

Time frame
5 years

Secondary outcomes

1

Number of participants with development of each hepatic decompensation event

Hepatic decompensation events include ascites, variceal bleeding and overt hepatic encephalopathy

Time frame
5 years
2

Number of participants with development of hepatocellular carcinoma

Development of hepatocellular carcinoma

Time frame
5 years
3

Change in hepatic function in terms of Child-Pugh score

Higher Child-Pugh score indicates poorer liver condition, vice versa

Time frame
5 years
4

Change in hepatic function in terms of model for end-stage liver disease (MELD) score

Higher MELD score indicates poorer liver condition, vice versa

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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