Statins for Prevention of Disease Progression and Hospitalization in Liver Cirrhosis

• Status: Recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In a randomized, doubleblind and placebo-controlled trial we assess both clinical and cellular effects of atorvastatin in patients with liver cirrhosis.

162 participants will be allocated to atorvastatin 10-20 mg or placebo for 18 months. Clinical outcomes of survival, hospitalizations and safety will be evaluated. Also, the trial will investigate cellular functions in the liver by mass spectrometry proteomics, and single cell transcriptomics as well as exploring atorvastatin effects on different fenotypes by metagenomics.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Copenhagen University Hospital, Hvidovre
• Collaborators: Aarhus University Hospital; Rigshospitalet, Denmark; University of Copenhagen
• Treatments: Atorvastatin

Criteria

Inclusion Criteria:

• Patients in the age of 18 to 80 years

• Patients with liver cirrhosis, diagnosed by liver biopsy or ultrasound or CT scan of the liver and clinical biochemistry compatible with cirrhosis within the past 3 months.

• In women, documented absence of pregnancy and unless in menopause commitment to use adequate contraception.

• Clinically significant portal hypertension with a hepatic venous pressure gradient measured by liver vein catheterization >10 mmHg.

• Ability to read and understand project information in Danish and give written, informed consent.

Exclusion Criteria:

• People treated with statins within the last year.

• People with liver cirrhosis, with a clinically verified infection (standard biochemistry, culture) within the last four weeks.

• Pregnancy or lactation.

• Hepatocellular carcinoma

• HIV infection and treatment with protease inhibitors

• People in whom the clinician and investigators may have reason to doubt compliance to trial medication

• Clinical and biochemical signs of hepato-renal syndrome defined by current guidelines (EASL) within the last 14 days

• A MELD score above 23, or Child-Pugh score higher than 13.

• Hepatic encephalopathy grade 2 or higher