Status:
TERMINATED
Statins for Prevention of Disease Progression and Hospitalization in Liver Cirrhosis
Lead Sponsor:
Copenhagen University Hospital, Hvidovre
Collaborating Sponsors:
University of Copenhagen
Aarhus University Hospital
Conditions:
Liver Cirrhoses
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 atorvast...
Detailed Description
Introduction Several studies have demonstrated the beneficial effects of statins in vascular and heart disease. Statins have antithrombotic effects, decrease oxidative stress and inflammation at the v...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04072601
Start Date
November 8 2019
End Date
January 10 2023
Last Update
January 13 2023
Active Locations (1)
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1
Gastro Unit, medical Division, University Hospital Hvidovre
Hvidovre, Danmark, Denmark, 2650