Study of Metformin Effects on Liver Pressure in Adults with Cirrhosis and Portal Hypertension Treated with Carvedilol

What this Trial Is About

Portal hypertension is a condition where pressure between the portal vein and hepatic veins is elevated, leading to serious complications in people with cirrhosis. This study focuses on patients with cirrhosis who have a high hepatic venous pressure gradient HVPG of 12 mm Hg or more, which increases the risk of variceal bleeding. Researchers aim to evaluate whether adding metformin to the standard carvedilol treatment can reduce this pressure more effectively than a placebo. Participants will be randomly assigned to receive either metformin or a placebo pill twice daily for 28 days, in addition to their existing carvedilol treatment. The study is designed as a national, multicenter, phase II, randomized, placebo-controlled trial with two parallel groups. The main focus is to compare the effects of metformin versus placebo on HVPG after 28 days. During the study, participants will have their HVPG measured to assess changes. Researchers will also monitor safety, tolerability, liver and spleen stiffness using elastography, systemic hemodynamics, liver steatosis, and markers of inflammation, coagulation, and liver cell stress. The total participation lasts at least 28 days, with follow-up assessments to evaluate treatment effects and safety.

Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension