Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis

NCT06764966 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 24-1117
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Decompensated Cirrhosis; Decompensated Liver Disease; Statins; Beta-Blockers; Cirrhosis

Outcome Measures

Primary Outcomes (2)

• 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

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

  12 months

Secondary Outcomes (6)

• Safety - Adverse events

  12 months

• New Decompensating events

  12 months

• Hepatic transaminases levels

  12 months

• Survival rate

  12 months

• Transplant-free survival rate

  12 months

Study Arms (2)

NSBB plus statin

ACTIVE COMPARATOR

Atorvastatin 20 mg once daily along with previously prescribed NSBB

Drug: Atorvastatin 20 mg

NSBB plus placebo

PLACEBO COMPARATOR

Placebo once daily along with previously prescribed NSBB

Drug: Placebo

Interventions

Atorvastatin 20 mg DRUG

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

NSBB plus statin

Placebo DRUG

Placebo Once Daily along with previously prescribed Non Selective Beta Blocker

NSBB plus placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

RECRUITING

MeSH Terms

Conditions

Fibrosis; Ascites

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Nadeem Anwar, MD

  CAMC Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadeem Anwar, MD

CONTACT

304-351-1700; nadeem.anwar@vandaliahealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chair, Gastroenterology

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 9, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)