Atorvastatin + Beta Blockers for Liver Cirrhosis

Recruiting in Palo Alto (17 mi)

Overseen byNadeem Anwar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: CAMC Health System

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Nadeem Anwar, MD

Principal Investigator

CAMC Health System

Eligibility Criteria

This trial is for patients with advanced liver disease (decompensated cirrhosis) who often face complications like fluid in the abdomen or mental confusion. Participants should not have other conditions that could interfere with the study or be taking medications that might conflict with the trial drugs.

Inclusion Criteria

I am 18 or older with advanced liver disease, seen at CAMC.

I am taking beta-blockers and agree to liver disease management by CAMC-Gastroenterology for 12 months.

Exclusion Criteria

Patients on the waitlist for liver transplantation

I have been diagnosed with liver cancer.

Patients with ongoing alcohol use (self-reported consumption of more than one alcoholic drink per week)

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Treatment Details

Interventions

Atorvastatin (Statins)
Placebo (Medication)

Trial OverviewThe study tests if adding atorvastatin, a statin drug, to a non-selective beta-blocker (a common treatment for liver disease), can help manage decompensated cirrhosis better than a beta-blocker alone. It's a pilot randomized controlled trial where half of the participants will receive atorvastatin and half will get a placebo.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: NSBB plus statinActive Control1 Intervention

Atorvastatin 20 mg once daily along with previously prescribed NSBB

Group II: NSBB plus placeboPlacebo Group1 Intervention

Placebo once daily along with previously prescribed NSBB