Statin and Beta Blocker Use in Patients with Decompensated Cirrhosis

Phase 2

Not yet recruiting

• Conditions: Decompensated Liver Cirrhosis; Cirrhosis; Decompensated Cirrhosis of Liver; Decompensated Cirrhosis and Ascites
• Interventions: Drug: Atorvastatin 20 mg; Drug: Placebo

• Registration Number: NCT06764966
• Lead Sponsor: CAMC Health System

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSBB plus statin	Atorvastatin 20 mg	Atorvastatin 20 mg once daily along with previously prescribed NSBB
NSBB plus placebo	Placebo	Placebo once daily along with previously prescribed NSBB

Primary Outcome Measures

Name	Time	Method
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	12 months	Participants will be considered compliant if they attend four follow-up visits and consume ≥ 75% of study medication (determined by pill counts)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charleston Area Medical Center; 🇺🇸 Charleston, West Virginia, United States