Prevention of Decompensation in Liver Cirrhosis - Full Text View

Prevention of Decompensation in Liver Cirrhosis

This study is currently recruiting participants.
Verified by Odense University Hospital, October 2005

Sponsors and Collaborators:	Odense University Hospital Lundbeck Fonden 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

MedlinePlus related topics:

Cirrhosis

ChemIDplus related topics:

Losartan Losartan potassium

U.S. FDA Resources

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

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 Fonden

University of Southern Denmark

Else Poulsen Mindelegat

Investigators


Principal Investigator:	Annette Dam, MD	Unaffiliated

More Information

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

Keywords provided by Odense University Hospital:

alcoholic liver cirrhosis

ascites

sodium retention

Study placed in the following topic categories:

Alcohol-Induced Disorders

Losartan

Liver Diseases

Fibrosis

Disorders of Environmental Origin

Liver Cirrhosis

Angiotensin II

Urinary Retention

Liver Diseases, Alcoholic

Digestive System Diseases

Ascites

Hypernatremia

Substance-Related Disorders

Alcohol-Related Disorders

Liver Cirrhosis, Alcoholic

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Cardiovascular Agents

Anti-Arrhythmia Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008