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Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis

RecruitingPhase 2Ages 18 Years - anyAllCAMC Health System
NCT06764966 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Decompensated cirrhosis (liver disease) occurs when liver function decreases to the extent that serious complications develop and can include internal bleeding, fluid buildup in the abdomen, or mental confusion. This reduced decreased liver function subsequently decreases life expectancy. There is a critical need for strategies to delay progression to decompensation and reduce the occurrence of serious complications. Currently, limited therapeutic options are available for managing decompensated liver disease, with beta-blockers (BB) being the only proven medication with significant benefits in preventing disease progression. Statins have been historically under- prescribed in cirrhosis due to concerns of liver damage. However, there is emerging evidence that statin use may be beneficial and able to lessen liver disease worsening, with studies demonstrating its safety. Thus, we aim to co

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients age of 18 years or older diagnosed with any form of decompensated liver disease defined as ascites, hepatic encephalopathy, or variceal bleed presenting at Charleston Area Medical Center (CAMC) Memorial Hospital or CAMC-Gastroenterology Liver Clinic * Currently on an non-selective beta-blockers agreeing to have their liver disease managed by CAMC-Gastroenterology Liver Clinic as an outpatient for the 12-month follow-up period. Exclusion Criteria: * Any patient \<18 years of age * Patients with hepatocellular carcinoma * Patients with ongoing alcohol use (self-reported consumption of more than one alcoholic drink per week) * Patients exhibiting high-risk behaviors that could put them at risk for complications including IV substance use and history of medication non-adherence * Patients currently on statin therapy * Patients with a history of statin intolerance * Patients on the waitlist for liver transplantation * Patients taking medications with known drug interactions with statins * Patients not able to give informed consent or patients belonging to vulnerable categories as the Federal Regulations or Common Rule
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What it tests

  • Atorvastatin 20 mg
  • Placebo
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Where

1 site
Charleston Area Medical Center
Charleston, United States
🤝 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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