Atorvastatin plus beta-blockers for people with decompensated cirrhosis
A Pilot Study of Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis
This pilot Phase 2 trial will test whether adding atorvastatin 20 mg to standard non‑selective beta‑blocker therapy helps adults with decompensated cirrhosis avoid complications over 12 months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CAMC Health System Academic / other |
| Locations | 1 site (Charleston, West Virginia) |
| Trial ID | NCT06764966 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo‑controlled Phase 2 pilot trial will enroll about 50 adults with decompensated liver cirrhosis who are already taking non‑selective beta‑blockers. Participants will be randomly assigned to atorvastatin 20 mg daily or matching placebo and followed as outpatients at the CAMC Gastroenterology Liver Clinic for 12 months. The study will monitor clinical events such as ascites, hepatic encephalopathy, variceal bleeding, safety signals, and routine laboratory markers of liver function to see if statin therapy reduces disease worsening. Because statins have historically been underused in cirrhosis over safety concerns, the trial places particular emphasis on tolerability and adverse event monitoring in this population.
Who should consider this trial
Good fit: Adults (≥18) with decompensated cirrhosis defined by ascites, hepatic encephalopathy, or variceal bleeding who are currently on a non‑selective beta‑blocker and can be followed at CAMC for 12 months are the intended participants.
Not a fit: People already on statins, with hepatocellular carcinoma, ongoing alcohol use, known statin intolerance, on a liver transplant waitlist, or with behaviors putting them at high risk for nonadherence are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, adding atorvastatin could slow progression of decompensated cirrhosis and reduce serious complications such as bleeding, ascites, or encephalopathy.
How similar studies have performed: Prior observational studies and some early trials suggest statins are generally safe in cirrhosis and may reduce complications, but randomized evidence specifically in decompensated patients is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charleston, West Virginia
- Charleston Area Medical Center — Charleston, West Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Nadeem Anwar, MD — CAMC Health System
- Study coordinator: Nadeem Anwar, MD
- Email: nadeem.anwar@vandaliahealth.org
- Phone: 304-351-1700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.