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Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis

NCT06764966 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-25

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

  • CAMC Health System

    lead OTHER

Principal Investigators

  • Nadeem Anwar, MD · CAMC Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06764966 on ClinicalTrials.gov