Ascites Clinical Trial
Official title:
Losartan in the Prevention of Sodium Retention and Ascites in Liver Cirrhosis – a Prospective Randomized Long-Term Study
The purpose of this study is to determine whether losartan, an angiotensin II blocker prevents the sodium retention in patients with liver cirrhosis and by that reduces the fluid retention. Moreover is the purpose to asses whether losartan is antifibrotic.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 2011 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: The presence of cirrhosis in a liver biopsy; or, in the absence of histology, clinical and laboratory evidence of cirrhosis combined with years of excessive alcohol intake. Age 18-70 years Exclusion Criteria: 1. Cirrhosis due to alpha1-antitrypsin deficiency, viral hepatitis or autoimmunity. 2. Renal disease evidenced by proteinuria > 0,5 g/day. 3. Heart disease 4. Hypertension 5. Cancer or disease other than cirrhosis expected to limit life expectancy to < 5 years. 6. Pregnancy or lactation 7. Sepsis within 5 days 8. Gastrointestinal bleeding within 5 days |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital | Else Poulsen Mindelegat, Lundbeck Foundation, University of Southern Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death | |||
Secondary | varices | |||
Secondary | need for therapeutic ascites drainage | |||
Secondary | gastrointestinal bleeding episodes |
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