Statin and Beta Blocker Use in Patients with Decompensated Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Decompensated Liver Cirrhosis Cirrhosis Decompensated Cirrhosis of Liver Decompensated Cirrhosis and Ascites

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NSBB plus statin

Atorvastatin 20 mg once daily along with previously prescribed NSBB

Group Type ACTIVE_COMPARATOR

Atorvastatin 20 mg

Intervention Type DRUG

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

NSBB plus placebo

Placebo once daily along with previously prescribed NSBB

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Once Daily along with previously prescribed Non Selective Beta Blocker

Interventions

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Atorvastatin 20 mg

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

Intervention Type DRUG

Placebo

Placebo Once Daily along with previously prescribed Non Selective Beta Blocker

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No