Actively Recruiting
Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis
Led by CAMC Health System · Updated on 2026-02-25
50
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 a non-selective beta-blocker
- Agree to have their liver disease managed by CAMC-Gastroenterology Liver Clinic as an outpatient for the 12-month follow-up period
You will not qualify if you...
- Patients younger than 18 years
- Patients with hepatocellular carcinoma
- Patients with ongoing alcohol use (more than one alcoholic drink per week)
- Patients exhibiting high-risk behaviors 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 interactions with statins
- Patients unable to give informed consent or belonging to vulnerable categories as defined by federal regulations
AI-Screening
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Trial Site Locations
Total: 1 location
1
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
Actively Recruiting
Research Team
N
Nadeem Anwar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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