Prevention of Decompensation in Liver Cirrhosis

This study is currently recruiting participants.

Verified by Odense University Hospital, October 2005

First Received: October 12, 2005 Last Updated: October 13, 2005 History of Changes

Sponsor:	Odense University Hospital
Collaborators:	Lundbeck Foundation University of Southern Denmark Else Poulsen Mindelegat
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00239096

Purpose

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.

Condition	Intervention	Phase
Alcoholic Liver Cirrhosis Ascites	Drug: losartan (drug)	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Losartan in the Prevention of Sodium Retention and Ascites in Liver Cirrhosis – a Prospective Randomized Long-Term Study

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis

Drug Information available for: Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

Death

Secondary Outcome Measures:

varices
need for therapeutic ascites drainage
gastrointestinal bleeding episodes

Estimated Enrollment:	100
Study Start Date:	September 2005
Estimated Study Completion Date:	September 2011

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

Cirrhosis due to alpha1-antitrypsin deficiency, viral hepatitis or autoimmunity.
Renal disease evidenced by proteinuria > 0,5 g/day.
Heart disease
Hypertension
Cancer or disease other than cirrhosis expected to limit life expectancy to < 5 years.
Pregnancy or lactation
Sepsis within 5 days
Gastrointestinal bleeding within 5 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239096

Contacts

Contact: Ove B. Schaffalitzky de Muckadell, Professor

0045 65412750

sdm@ouh.fyns-amt.dk

Locations

Denmark
Odense University Hospital	Recruiting
Odense, Denmark, 5000
Contact: Ove B Schaffalitzky de Muckadell, Professor 0045 65412750 sdm@ouh.fyns-amt.dk
Principal Investigator: Annette Dam, MD

Sponsors and Collaborators

Odense University Hospital

Lundbeck Foundation

University of Southern Denmark

Else Poulsen Mindelegat

Investigators

Principal Investigator:

Annette Dam, MD

Unaffiliated

More Information

No publications provided

Study ID Numbers:	VF20040245, Eudra CT: 2005-001191-12
Study First Received:	October 12, 2005
Last Updated:	October 13, 2005
ClinicalTrials.gov Identifier:	NCT00239096 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:

alcoholic liver cirrhosis
ascites
sodium retention

Additional relevant MeSH terms:

Alcohol-Induced Disorders
Liver Diseases
Losartan
Molecular Mechanisms of Pharmacological Action
Fibrosis
Disorders of Environmental Origin
Cardiovascular Agents
Liver Cirrhosis
Antihypertensive Agents
Pharmacologic Actions

Angiotensin II Type 1 Receptor Blockers
Liver Diseases, Alcoholic
Pathologic Processes
Digestive System Diseases
Ascites
Therapeutic Uses
Substance-Related Disorders
Alcohol-Related Disorders
Anti-Arrhythmia Agents
Liver Cirrhosis, Alcoholic

ClinicalTrials.gov processed this record on February 08, 2010