Prevention of Decompensation in Liver Cirrhosis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2005 by Odense University Hospital. Recruitment status was Recruiting

First Received on October 12, 2005. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
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:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

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

More Information

No publications provided

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

Keywords provided by Odense University Hospital:

alcoholic liver cirrhosis
ascites
sodium retention

Additional relevant MeSH terms:

Ascites
Hypernatremia
Liver Cirrhosis
Fibrosis
Liver Cirrhosis, Alcoholic
Pathologic Processes
Water-Electrolyte Imbalance
Metabolic Diseases
Liver Diseases
Digestive System Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders

Alcohol-Related Disorders
Substance-Related Disorders
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012