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 study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Hopitaux Universitaires Pitie Salpetriere Paris France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Paul Brousse Villejuif France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hopital Saint Joseph Marseille France
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Hjlgupax cpceql Hmcho Miqbor ij Avtesteo Aurillac France
Cfpdyf Hfenddryahc Upszkdycicfhj Dj Duhqv Dijon France
Bqadliyi Uhpqbhxxuf Hqgjkynr Clxfjb Besançon France
Cvojus Hpxsczxmhvn Rzythxxq Umxvlplezjhmw Dq Tpbsg Tours France
Copscn Hfyvkcnfpyd Rqruezmd Djxcnhffvxqfbv Angers France
Hvsdlfqu Ucxlomcfbgjxfx Sovjdsridn &lzqexr Hwydzeo dd Hzkqiwaghts STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
05.05.2025

Trial locations

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.

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 ID:
2024-511663-28-00
Protocol code:
CARVECIR
NCT ID:
NCT06263816
Trial Phase:
Therapeutic confirmatory (Phase III)

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