Preventing complications of liver cirrhosis with simvastatin and AI monitoring
Official title: Liver Cirrhosis Network: Clinical Research Center - Mayo Clinic
Funded at Mayo Clinic Rochester · NIH-11168915 · Data updated 2026-11-12
This project compares daily simvastatin to placebo and uses AI on clinical and imaging data to help people with compensated cirrhosis avoid complications.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Mayo Clinic Rochester NIH-funded |
| Lab location | 1 site (Rochester, United States) |
| Project start | September 13, 2021 |
| Project end | July 31, 2026 |
| Funding year | 2025 |
| Award (this year) | $397,500 |
| NIH project number | 5U01DK130181-05 |
| Project ID | NIH-11168915 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with compensated liver cirrhosis who meet safety criteria for statin use and can attend follow-up at participating centers are the ideal candidates.
✕Less likely to help
People with decompensated cirrhosis, active liver failure, contraindications to statins, or inability to undergo required imaging or follow-up may not benefit or be eligible.
What this research studies
You would be followed in a multicenter program that collects clinical information, blood samples, imaging including magnetic resonance elastography, and ECGs over time. Those data will be used to build and validate an AI algorithm that aims to predict who will develop cirrhosis complications. In a randomized phase 3 trial, participants will receive simvastatin 20 mg daily or placebo to test whether the medicine reduces complications and mortality. The program also supports lab studies using stored biological samples to understand mechanisms.
Why it matters
Potential benefit: If successful, this work could identify people at high risk earlier and reduce cirrhosis complications and deaths through prediction tools and a widely available medication.
How similar studies have gone: Smaller studies have suggested statins may improve liver function and lower portal pressure and early AI models show promise for predicting decompensation, but a large randomized phase 3 trial like this has not yet produced definitive proof.
Where this research is happening
-
Mayo Clinic Rochester
Rochester, United States Active
Researchers
- Principal investigator: Shah, Vijay H. — Mayo Clinic Rochester
- Study coordinator: Shah, Vijay H.
Related research
Other NIH-funded projects on the same topics.
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Liver Cirrhosis Network: Centers for Clinical Research
A multicenter study in people with cirrhosis from different causes (including HIV, NASH, and alcohol-related liver disease) to collect data and samples and test new ways to predict and monitor disease progression.
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Liver Cirrhosis Network: Mayo Clinic's Clinical Research Center
A Mayo Clinic-led project will follow and help people with compensated cirrhosis, using data, imaging, and a big AI tool to predict when complications may happen and test whether a statin can improve outcomes.
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Liver Cirrhosis Network: Longitudinal and Clinical Trial Studies
A network-wide NIH study focused on understanding cirrhosis better to prevent complications and improve care for people with advanced liver disease.
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Liver Cirrhosis Network: Coordinating Data for Better Care
A national effort is coordinating data to improve care for people with advanced liver disease and its complications.
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Liver Cirrhosis Network coordinating cirrhosis studies and a rosuvastatin trial
This project follows people with liver cirrhosis over time and tests whether the cholesterol medicine rosuvastatin helps people with cirrhosis.
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First-in-class treatment for liver cirrhosis with portal hypertension
A new therapy called XFB19 aims to reduce liver inflammation and scarring in people with advanced liver disease and portal hypertension.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.