Recruiting
Phase 2

Atorvastatin & BB

Sponsor:

CAMC Health System

Code:

NCT06764966

Conditions

Decompensated Liver Cirrhosis

Cirrhosis

Decompensated Cirrhosis of Liver

Decompensated Cirrhosis and Ascites

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Atorvastatin 20 mg

Placebo

Study Details

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

Study ID

NCT06764966

Start date

Sep 9, 2025

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: NSBB plus statin

Atorvastatin 20 mg once daily along with previously prescribed NSBB

placebo comparator: NSBB plus placebo

Placebo once daily along with previously prescribed NSBB

Interventions

Atorvastatin 20 mg

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

Placebo

Placebo Once Daily along with previously prescribed Non Selective Beta Blocker

Primary outcome measure

  • Feasibility- compare the number of participants who discontinued study medication for any reason during the 12-month follow-up period [ Time Frame: 12 months ]
  • Feasibility- compare the number of participants compliant with study treatment [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Nadeem Anwar, MD

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

Locations

Charleston Area Medical Center

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

Nadeem Anwar, MD

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

Principal Investigator:

Nadeem Anwar, MD

More Information

Sponsor

CAMC Health System

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CAMC Health System on 2026-02-25.