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

RecruitingNAAges 18 Years - 65 YearsAllPost Graduate Institute of Medical Education and …
NCT06431919 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Simvastatin 20mg
  • Carvedilol 3.125 mg
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Where

1 site
PGIMER, Department of Hepatology
Chandigarh, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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