Study of Simvastatin Plus Carvedilol Versus Carvedilol Alone in Adults With Cirrhosis and Cirrhotic Cardiomyopathy to Improve Heart Function and Reduce Liver Complications and Death

What this Trial Is About

Cirrhosis and portal hypertension often lead to complications like ascites, variceal bleeding, acute kidney injury, and infections. Cirrhotic cardiomyopathy CCM, affecting 30-70% of these patients, involves structural and functional heart changes and is linked to worsening cirrhosis, lower quality of life, and higher mortality. This trial studies the effects and safety of simvastatin, in combination with carvedilol, compared to carvedilol alone, on CCM and related complications in a controlled, randomized setting. Participants receive either simvastatin 20 mg daily plus carvedilol starting at 3.125 mg twice daily adjusted weekly to reach a target heart rate along with standard medical therapy, or carvedilol with standard therapy alone. The study is double-blinded and placebo-controlled, assessing the combined effects of these drugs on cardiac remodeling, portal blood flow, and prevention of liver decompensation events. Treatment and monitoring occur over a one-year period. During the study, participants undergo comprehensive cardiac evaluations including imaging and biomarker tests, along with clinical monitoring for liver-related complications and survival outcomes. The primary measure is time to acute decompensation within one year, with secondary outcomes including all-cause mortality, hospitalization episodes, cardiac function improvement, and inflammatory markers. This process will provide detailed data on how simvastatin may impact CCM and liver disease progression over the study duration.

Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival