NCT00239096

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 14, 2005

Status Verified

October 1, 2005

First QC Date

October 12, 2005

Last Update Submit

October 13, 2005

Conditions

Alcoholic Liver CirrhosisAscites

Keywords

alcoholic liver cirrhosisascitessodium retention

Outcome Measures

Primary Outcomes (1)

  • Death

Secondary Outcomes (3)

  • varices

  • need for therapeutic ascites drainage

  • gastrointestinal bleeding episodes

Interventions

losartan (drug)DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, AlcoholicAscitesHypernatremia

Interventions

LosartanPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Liver CirrhosisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Annette Dam, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ove B. Schaffalitzky de Muckadell, Professor

CONTACT

0045 65412750sdm@ouh.fyns-amt.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 14, 2005

Study Start

September 1, 2005

Study Completion

September 1, 2011

Last Updated

October 14, 2005

Record last verified: 2005-10

Locations

DK(1)