Preventing complications of liver cirrhosis with simvastatin and AI monitoring
Liver Cirrhosis Network: Clinical Research Center - Mayo Clinic
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 ID | NIH-11168915 on NIH RePORTER |
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.
Who could benefit from this research
Good fit: Adults with compensated liver cirrhosis who meet safety criteria for statin use and can attend follow-up at participating centers are the ideal candidates.
Not a fit: 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.
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 performed: 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
Rochester, United States
- Mayo Clinic Rochester — Rochester, United States (Active)
Researchers
- Principal investigator: Shah, Vijay H. — Mayo Clinic Rochester
- Study coordinator: Shah, Vijay H.
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 below.