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Prevention of Decompensation in Liver Cirrhosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2005 by Odense University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00239096
First Posted: October 14, 2005
Last Update Posted: October 14, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Lundbeck Foundation
University of Southern Denmark
Else Poulsen Mindelegat
Information provided by:
Odense University Hospital
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00239096     History of Changes
Other Study ID Numbers: VF20040245
Eudra CT: 2005-001191-12
First Submitted: October 12, 2005
First Posted: October 14, 2005
Last Update Posted: October 14, 2005
Last Verified: October 2005

Keywords provided by Odense University Hospital:
alcoholic liver cirrhosis
ascites
sodium retention

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Ascites
Liver Cirrhosis, Alcoholic
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action