NCT06431919 Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival

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This trial targets 260 participants in total. It began in 2025-06-10 with a primary completion date of 2028-01-31.

Brief Summary

Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections. Rationale: Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including ascites, variceal bleeding, acute kidney injury, and susceptibility to infections. CCM, present in 30-70% of patients, is characterized by structural and functional abnormalities in the heart, and is associated with progression of cirrhosis, impaired quality of life and poor survival. Statins play a crucial role in reducing proatherogenic LDL cholesterol levels, making them a cornerstone in managing diabetes and cardiovascular diseases (CVDs) with the aim of decreasing or reversing atherosclerosis. This trial aims to evaluate the impact and safety of simvastatin in cirrhotic cardiomyopathy. Novelty: Simvastatin might be of special value in diastolic dysfunction through its hemodynamic and functional effects on LV remodeling and improve portal hemodynamics through the pleotropic effects of lipophilic statins. Objectives: The primary objective is to assess the combined effects of carvedilol and simvastatin in managing CCM vs carvedilol alone for a composite outcome to prevent decompensation and reduce all-cause mortality. We will comprehensively evaluate cardiac function, decompensation events and survival based on impact of simvastatin over the standard betablocker carvedilol. Methods: This is a double-blinded randomized placebo-controlled trial involving patients diagnosed with CCM. Clinical data, including cardiac imaging, cardiac biomarkers, and survival outcomes, will be assessed for either group. Expected Outcome: The investigators anticipate that the synergistic use of simvastatin and carvedilol will effectively reduce portal pressure, improve portal haemodynamic, and enhance cardiac remodelling. Successful reversal of LVDD can potentially prevent clinical events such as ascites, encephalopathy, and acute kidney injury (AKI).

Eligibility Criteria

Inclusion Criteria: * Age range of 18-65 years * Compensated cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings, * CCM (with EF\>50%) on 2D echocardiography with TDI * Written informed consent. Exclusion Criteria: * Age \>65 years * Serum Creatinine\>2 mg/dl * Patient previously treated with statin (one month before the study) * Contraindications to statins * Advanced Cirrhosis (CTP score\>9) * Coronary artery disease * Sick sinus syndrome/ Pacemaker, valvular heart disease * Cardiac rhythm disorder, Peripartum cardiomyopathy * Portopulmonary hypertension/ hepatopulmonary syndrome * Transjugular intrahepatic portosystemic shunt (TIPS) insertion * Hepatocellular carcinoma * Pregnancy or lactation * Patients with HIV or retroviral therapy * Anemia Hb \< 8gm/dl in females, and \< 9 gm/dl in males * Acute variceal bleeding in last 6 months. * Need for medications, metabolized by CYP3A4(such as amlodipine, verapamil, fenofibrate azole antibiotics, protease inhibitors etc.)

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