Clinical trial NCT06764966: Statin and Beta Blocker Use in Patients with Decompensated Cirrhosis
Official title: A Pilot Study of Statin and Beta Blocker Use in Patients with Decompensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Decompensated Liver Cirrhosis
Cirrhosis
Decompensated Cirrhosis of Liver
Decompensated Cirrhosis and Ascites
Keywords: Decompensated Cirrhosis
Decompensated Liver Disease
Statins
Beta-Blockers
Cirrhosis
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility- compare the number of participants who discontinued study medication for any reason during the 12-month follow-up period
timeFrame: 12 months
measure: Feasibility- compare the number of participants compliant with study treatment
timeFrame: 12 months
Secondary outcomes:
measure: Safety - Adverse events
timeFrame: 12 months
measure: New Decompensating events
timeFrame: 12 months
measure: Hepatic transaminases levels
timeFrame: 12 months
measure: Survival rate
timeFrame: 12 months
measure: Transplant-free survival rate
timeFrame: 12 months
measure: Rate of Hepatocellular Carcinoma Diagnosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
Study officials:
affiliation: CAMC Health System
name: Nadeem Anwar, MD
role: PRINCIPAL_INVESTIGATOR
References: