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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Atorvastatin 20 mg Once Daily with previously prescribed Non Selective Beta-Blocker
Placebo Once Daily along with previously prescribed Non Selective Beta Blocker
Charleston Area Medical Center
Charleston, West Virginia, United States
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
Participants will be considered compliant if they attend four follow-up visits and consume ≥ 75% of study medication (determined by pill counts)
Time frame: 12 months
Safety - Adverse events
Rate of reported treatment-related adverse events (muscle pain, muscle injury, liver injury, kidney dysfunction, other)
Time frame: 12 months
New Decompensating events
Rate of new decompensating events (ascites, vatical bleeding, worsening jaundice, or encephalopathy) in each arm, time for development of new decompensating event
Time frame: 12 months
Hepatic transaminases levels
Number of participants with increases in transaminases by more than five times the upper limit of normal
Time frame: 12 months
Survival rate
Rate of survival between the two treatment arms
Time frame: 12 months
Transplant-free survival rate
Number of participants without liver transplant during study participation
Time frame: 12 months
Rate of Hepatocellular Carcinoma Diagnosis
Number of participants developing Hepatocellular Carcinoma over 12 months
Time frame: 12 months
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