Study Comparing Metformin Plus Carvedilol Versus Carvedilol Alone to Lower Portal Pressure in Adults with Liver Cirrhosis and Variceal Bleeding

What this Trial Is About

Researchers are evaluating treatments for liver cirrhosis patients who have clinically significant portal hypertension CSPH, a condition that increases the risk of serious complications like variceal bleeding and liver decompensation. This randomized, double-blind study aims to compare the effects of Metformin combined with Carvedilol versus Carvedilol alone on reducing portal pressure. The study focuses on measuring changes in hepatic venous pressure gradient HVPG, which helps assess the severity and risk related to portal hypertension. Participants will receive either Metformin 1000 mg plus Carvedilol 12.5 mg or Carvedilol 12.5 mg alone. These treatments are given to evaluate their immediate impact on portal pressure. The study is designed to observe acute changes within 2 hours after drug administration. Both groups will be monitored for changes in blood sugar, inflammatory markers, liver and spleen stiffness, and cardiac output. During the study, participants will have HVPG measurements taken to track the primary outcome of a significant decrease in portal pressure. Additional assessments include evaluating inflammatory markers and organ stiffness. The trial includes detailed monitoring of heart rate and blood pressure to ensure safety. Participation duration covers the acute assessment period following treatment, with close observation for any immediate effects during the 2-hour post-dose window.

Acute Portal Pressure Reduction by Metformin and Carvedilol Compared to Carvedilol Alone in Cirrhosis.