Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis

A Pilot Study of Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis

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 conduct a pilot randomized controlled trial (RCT) study of 50 subjects comparing the outcomes of decompensated cirrhotic patients receiving the statin, atorvastatin, and a non-selective beta-blocker (NSBB) versus those receiving NSBB plus placebo. Both groups will be followed for 12 months to investigate the feasibility, safety, and efficacy of combination therapy.

Study Overview

• Status: Recruiting
• Conditions: Cirrhosis; Decompensated Cirrhosis and Ascites; Decompensated Liver Cirrhosis; Decompensated Cirrhosis of Liver
• Intervention / Treatment: Drug: Atorvastatin 20 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nadeem Anwar, MD; Phone Number: 304-351-1700; Email: nadeem.anwar@vandaliahealth.org

Study Locations

• United States
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Recruiting
      • Charleston Area Medical Center
      • Contact: Nadeem Anwar, MD; Phone Number: 304-351-1700; Email: nadeem.anwar@vandaliahealth.org
      • Principal Investigator: Nadeem Anwar, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NSBB plus statin; Atorvastatin 20 mg once daily along with previously prescribed NSBB	Drug: Atorvastatin 20 mg; Atorvastatin 20 mg Once Daily with previously prescribed Non Selective Beta-Blocker
Placebo Comparator: NSBB plus placebo; Placebo once daily along with previously prescribed NSBB	Drug: Placebo; Placebo Once Daily along with previously prescribed Non Selective Beta Blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility- compare the number of participants who discontinued study medication for any reason during the 12-month follow-up period		12 months
Feasibility- compare the number of participants compliant with study treatment	Participants will be considered compliant if they attend four follow-up visits and consume ≥ 75% of study medication (determined by pill counts)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Adverse events	Rate of reported treatment-related adverse events (muscle pain, muscle injury, liver injury, kidney dysfunction, other)	12 months
New Decompensating events	Rate of new decompensating events (ascites, vatical bleeding, worsening jaundice, or encephalopathy) in each arm, time for development of new decompensating event	12 months
Hepatic transaminases levels	Number of participants with increases in transaminases by more than five times the upper limit of normal	12 months
Survival rate	Rate of survival between the two treatment arms	12 months
Transplant-free survival rate	Number of participants without liver transplant during study participation	12 months
Rate of Hepatocellular Carcinoma Diagnosis	Number of participants developing Hepatocellular Carcinoma over 12 months	12 months

Collaborators and Investigators

• Sponsor: CAMC Health System
• Investigators: Principal Investigator: Nadeem Anwar, MD, CAMC Health System

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cirrhosis; Statins; Decompensated Cirrhosis; Beta-Blockers; Decompensated Liver Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis; Ascites; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Azoles; Pyrroles; Heptanoic Acids; Atorvastatin
• Other Study ID Numbers: 24-1117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes