NCT00332904

Brief Summary

The study´s purpose is to investigate the effect of beta blockade or aldosterone antagonist therapy on oxygenation, peripheral and cardiac hemodynamics and humoral systems, in patients with liver cirrhosis.

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
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2006

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

First Submitted

Initial submission to the registry

May 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 4, 2010

Status Verified

June 1, 2010

Enrollment Period

1.9 years

First QC Date

May 31, 2006

Last Update Submit

June 3, 2010

Conditions

Liver CirrhosisPortal Hypertension

Keywords

betablockeraldosterone antagonistperipheral haemodynamicscardiac haemodynamicsoxygenation

Outcome Measures

Primary Outcomes (1)

  • effect of treatment on hemodynamic and cardiac parameters

    3 weeks

Study Arms (3)

beta

ACTIVE COMPARATOR

patients with liver cirrhosis, treated with betablocker

Drug: propranolol

spiron

ACTIVE COMPARATOR

patients with liver cirrhosis, treated with aldosterone antagonist

Drug: spironolactone

control

NO INTERVENTION

patients with liver cirrhosis, no treatment

Interventions

propranololDRUG

tablet 80 mg pr. day in a period of 3 weeks, evt. dose adjustment

beta
spironolactoneDRUG

tablet 200 mg pr. day in 3 weeks, evt. dose adjustment

spiron

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liver cirrhosis
  • Clinical indication for treatment with betablocker or aldosterone antagonist
  • Must not have been treated earlier with betablocker or aldosterone antagonist
  • Must have been alcohol abstinent for more than 4 weeks

You may not qualify if:

  • Gastrointestinal bleeding in the last 2 weeks
  • Encephalopathy \> grade 1
  • Acute medical conditions
  • Malignant disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Physiology and Nuclear Medicine, and Department for Gastrointestinal Medicine, Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Liver CirrhosisHypertension, Portal

Interventions

PropranololSpironolactone

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsLactonesPregnenesPregnanesSteroidsFused-Ring Compounds

Study Officials

  • Soeren Moeller, MD, DMSc

    Hvidovre University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2006

First Posted

June 2, 2006

Study Start

August 1, 2006

Primary Completion

July 1, 2008

Study Completion

December 1, 2010

Last Updated

June 4, 2010

Record last verified: 2010-06

Locations

DK(1)