Portal Hypertension study: Carvedilol
Official title Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease
ClinicalTrials.gov ID: NCT06449339
What this study is testing
What is Carvedilol?
an investigational oral medication being studied as a potential treatment for portal hypertension in patients with advanced chronic liver disease is designed to block beta receptors and reduce portal pressure by lowering heart rate and blood pressure
Also referred to as generic carvedilol.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether carvedilol can lower the chance of liver failure and death in patients with compensated advanced chronic liver disease and significant portal hypertension.
- Who it's for
- Adults who have advanced chronic liver disease with clinically significant portal hypertension but no varices that need treatment.
- What's involved
- Participants will either take carvedilol or not for up to five years, and will have regular clinic visits with blood tests, liver ultrasound, upper GI endoscopy, and a liver stiffness scan.
- Time commitment
- The trial lasts up to five years with periodic check‑up visits and the listed tests during the study.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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...
- Contraindication to NSBB (e.g. Type II/III heart block or baseline bradycardia \<60/minute, hypotension with systolic blood pressure (SBP) \<100...
- 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...
See the full eligibility 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)
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Hong Kong, Hong Kong
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hong Kong, Hong Kong. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.