Atorvastatin plus beta-blockers for people with decompensated cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo‑controlled Phase 2 pilot trial will enroll about 50 adults with decompensated liver cirrhosis who are already taking non‑selective beta‑blockers. Participants will be randomly assigned to atorvastatin 20 mg daily or matching placebo and followed as outpatients at the CAMC Gastroenterology Liver Clinic for 12 months. The study will monitor clinical events such as ascites, hepatic encephalopathy, variceal bleeding, safety signals, and routine laboratory markers of liver function to see if statin therapy reduces disease worsening. Because statins have historically been underused in cirrhosis over safety concerns, the trial places particular emphasis on tolerability and adverse event monitoring in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Charleston Area Medical Center
  Charleston, West Virginia, United States Recruiting

Study contacts

• Principal investigator: Nadeem Anwar, MD — CAMC Health System
• Study coordinator: Nadeem Anwar, MD
• Email: nadeem.anwar@vandaliahealth.org
• Phone: 304-351-1700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.