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NCT Number: NCT06764966

Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis

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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Key information

Conditions

Decompensated Liver Cirrhosis Ascites Cirrhosis Decompensated Cirrhosis and Ascites Decompensated Cirrhosis of Liver Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location status: Recruiting

Location contact

Nadeem Anwar, MD

CONTACT

[email protected]

304-351-1700

Nadeem Anwar, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atorvastatin 20 mg

Drug

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

Placebo

Drug

Placebo Once Daily along with previously prescribed Non Selective Beta Blocker

Primary outcomes

  1. Feasibility- compare the number of participants who discontinued study medication for any reason during the 12-month follow-up period

    Time frame: 12 months

  2. Feasibility- compare the number of participants compliant with study treatment

    Time frame: 12 months

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

Secondary outcomes

  1. Safety - Adverse events

    Time frame: 12 months

    Rate of reported treatment-related adverse events (muscle pain, muscle injury, liver injury, kidney dysfunction, other)

  2. New Decompensating events

    Time frame: 12 months

    Rate of new decompensating events (ascites, vatical bleeding, worsening jaundice, or encephalopathy) in each arm, time for development of new decompensating event

  3. Hepatic transaminases levels

    Time frame: 12 months

    Number of participants with increases in transaminases by more than five times the upper limit of normal

  4. Survival rate

    Time frame: 12 months

    Rate of survival between the two treatment arms

  5. Transplant-free survival rate

    Time frame: 12 months

    Number of participants without liver transplant during study participation

  6. Rate of Hepatocellular Carcinoma Diagnosis

    Time frame: 12 months

    Number of participants developing Hepatocellular Carcinoma over 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Nadeem Anwar, MD

CONTACT

[email protected]

304-351-1700

Sponsors and collaborators

Lead sponsor

CAMC Health System

Other

Registry information

Official study title

A Pilot Study of Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2025
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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