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Study on Carvedilol for Preventing Complications in Patients with Early-Stage Cirrhosis and High Blood Pressure in the Liver

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Carvedilol on patients with a liver condition known as cirrhosis. Cirrhosis is a disease where the liver becomes scarred and its function is impaired. The study specifically targets patients with a type of cirrhosis that is currently not causing symptoms, classified as Child-Pugh A5 to B8 cirrhosis, and who also have a condition called clinically significant portal hypertension. Portal hypertension is an increase in blood pressure within the portal vein, which carries blood from the digestive organs to the liver.

The purpose of the study is to evaluate whether taking a low dose of Carvedilol (up to 12.5 mg per day) can prevent the worsening of cirrhosis or liver-related death over a period of 36 months. Participants in the study will be randomly assigned to receive either the medication or a placebo, which looks like the medication but does not contain any active ingredients. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will be monitored for any changes in their condition, including the occurrence of cirrhosis complications or liver-related death. The safety of Carvedilol will also be assessed by observing its effects on heart rate, blood pressure, and overall cardiac function. Additionally, researchers will look for any potential predictors of how patients respond to the treatment, such as changes in liver and spleen stiffness or variations in heart rate and blood pressure. The study aims to provide valuable insights into the management of cirrhosis and improve outcomes for patients with this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of asymptomatic Child-Pugh A5 to B8 cirrhosis and ensuring no high-risk varices are present.

    Eligibility criteria include being 18 years or older, having cirrhosis related to specific causes, and meeting certain medical conditions. Written consent is required.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either carvedilol or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

  3. Step 3

    Medication administration

    Participants take carvedilol tablets orally, with a dosage of up to 12.5 mg per day. The exact dosage is determined by the study protocol and may vary based on individual response.

    The medication is taken daily for the duration of the study, which lasts up to 36 months.

  4. Step 4

    Regular monitoring

    Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes checking heart rate, blood pressure, and cardiac function.

    Participants are required to keep a record of unused medication packaging and maintain a patient notebook to track compliance.

  5. Step 5

    Follow-up assessments

    Follow-up assessments occur at specified intervals, including baseline, week 2, and month 12. These assessments measure liver and spleen stiffness and other health indicators.

    The primary goal is to observe any occurrence of cirrhosis decompensation or liver-related death within 36 months.

  6. Step 6

    Study completion

    The study concludes after 36 months. Final assessments are conducted to evaluate the long-term effects of the treatment.

    The study aims to identify predictors of treatment response and potential risks associated with carvedilol use.

Who can join the trial?

8 criteria

  • Must be a male or female who is at least 18 years old.
  • Must have **cirrhosis** (a type of liver disease) caused by hepatitis C or B virus without the virus being active for at least 2 years, or caused by alcohol use (whether currently drinking or not), or caused by **metabolic syndrome** (a group of conditions that increase the risk of heart disease, stroke, and diabetes) or unknown reasons with a **BMI** (Body Mass Index) less than 30.
  • Must have had two **TE-LSM** (a liver stiffness measurement test called Fibroscan®) done while fasting, with results of 25 kPa or more, within 12 months before joining the study.
  • Must not have medium or large **varices** (enlarged veins) or small varices with red signs, as checked by an **endoscopy** (a procedure to look inside the body) within 3 months before joining the study.
  • Must have a **Child-Pugh score** between A5 and B8, which is a system used to assess the severity of liver disease.
  • Must be affiliated with the French social security system.
  • Must provide written informed consent, either personally or through a legal representative.
  • Women of child-bearing age must use contraception, such as oral contraceptives, an intrauterine device, or mechanical contraception.

Who cannot join the trial?

7 criteria

  • Patients with **symptoms** of cirrhosis cannot participate. **Cirrhosis** is a condition where the liver is scarred and doesn't work properly.
  • Patients with **Child-Pugh class** higher than B8 are excluded. The **Child-Pugh score** is a system used to measure the severity of liver disease.
  • Patients with **TE-LSM** less than 25 kPa are not eligible. **TE-LSM** stands for Transient Elastography Liver Stiffness Measurement, a test to check how stiff the liver is.
  • Patients with **high-risk varices** cannot join. **Varices** are swollen veins, often in the esophagus or stomach, that can bleed.
  • Patients who are not within the specified **age range** are excluded. The age range for this study is not specified here.
  • Both **male and female** patients can participate, but those who do not meet other criteria are excluded.
  • Patients from a **vulnerable population** are not included. This means people who might need special protection or care.
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Investigated drugs

Carvedilol is a medication used in this trial to see if it can help prevent worsening of liver disease or death in patients with a specific type of liver condition called cirrhosis. The trial is testing whether taking carvedilol can help people with this condition live longer without their disease getting worse.

What is already known about the treatment

Carvedilol – Carvedilol is administered orally in tablet form. It is currently being studied in clinical trials to assess its effectiveness in preventing liver complications or death in patients with early-stage cirrhosis, specifically those classified as Child-Pugh A5 to B8. The main therapeutic indication for carvedilol in this trial is to prevent the progression of liver disease in patients with significant portal hypertension but without high-risk varices. At the molecular level, carvedilol works by blocking certain receptors in the heart and blood vessels, which helps to lower blood pressure and reduce the workload on the heart. It is classified as a non-selective beta-blocker with additional alpha-blocking activity.

Investigated diseases

Cirrhosis – Cirrhosis is a condition where the liver becomes scarred and its function is gradually impaired. It often develops over many years due to chronic liver damage from various causes such as alcohol abuse, viral infections, or metabolic disorders. In the early stages, cirrhosis may not present any symptoms, but as it progresses, it can lead to complications like fluid buildup in the abdomen, bleeding, and confusion. The liver's ability to perform its vital functions, such as detoxifying the blood and producing essential proteins, diminishes over time. As cirrhosis advances, the risk of liver failure and other serious health issues increases. Monitoring and managing the condition is crucial to prevent further liver damage and complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511663-28-00Protocol codeCARVECIREstimated enrolment300 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).