Statin and Beta Blocker Use in Patients with Decompensated Cirrhosis

CAMC Health System

Status and phase: Not yet enrolling; Phase 2

Conditions: Decompensated Cirrhosis and Ascites; Decompensated Cirrhosis of Liver; Cirrhosis; Decompensated Liver Cirrhosis

Treatments: Drug: Atorvastatin 20 mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06764966

24-1117

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

NSBB plus statin

Active Comparator group

Description:

Atorvastatin 20 mg once daily along with previously prescribed NSBB

Treatment:

Drug: Atorvastatin 20 mg

NSBB plus placebo

Placebo Comparator group

Description:

Placebo once daily along with previously prescribed NSBB

Treatment:

Drug: Placebo