Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis

Part of paid clinical trials in Charleston, West Virginia.

Sponsor
CAMC Health System
Study ID
NCT06764966
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cirrhosis
  • Decompensated Cirrhosis and Ascites
  • Decompensated Cirrhosis of Liver
  • Decompensated Liver Cirrhosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Sep 9, 2025
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: NSBB plus statin
    Atorvastatin 20 mg once daily along with previously prescribed NSBB
  • Placebo Comparator: NSBB plus placebo
    Placebo once daily along with previously prescribed NSBB

Primary Outcome Measure

Feasibility- compare the number of participants who discontinued study medication for any reason during the 12-month follow-up period [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Charleston Area Medical CenterCharlestonWest Virginia25304
Nadeem Anwar, MD
[email protected]
304-351-1700
Nadeem Anwar, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Charleston Area Medical Center· Charleston, WV

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