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.



France