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RECRUITING
NCT06764966
PHASE2

Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis

Sponsor: CAMC Health System

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-09-09

Completion Date

2027-03

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

DRUG

Atorvastatin 20 mg

Atorvastatin 20 mg Once Daily with previously prescribed Non Selective Beta-Blocker

DRUG

Placebo

Placebo Once Daily along with previously prescribed Non Selective Beta Blocker

Locations (1)

Charleston Area Medical Center

Charleston, West Virginia, United States