Effect of Betablocker or Aldosterone Antagonist Therapy on Patients With Liver Cirrhosis

NCT ID: NCT00332904

Last Updated: 2010-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Cardio-pulmonal complications to patients with liver cirrhosis and portal hypertension determine the patients' prognosis. Most patients have hemodynamical changes in circulation with increased cardiac output and decreased systolic function in stress. Endothelial dysfunction is a parameter for bad prognosis in cardiovascular disease. The Renin-angiotensin-aldosterone-system plays an important role in natrium and volume regulation. Descriptions of changes in the peripheral circulation and oxygenation have been deficient up to now.

Patients with liver cirrhosis and portal hypertension are betablockers and/or aldosterone antagonists routine treatment - effects on peripheral hemodynamics and oxygenation in relation to central hemodynamic changes are deficient.

Conditions

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Liver Cirrhosis Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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beta

patients with liver cirrhosis, treated with betablocker

Group Type ACTIVE_COMPARATOR

propranolol

Intervention Type DRUG

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

spiron

patients with liver cirrhosis, treated with aldosterone antagonist

Group Type ACTIVE_COMPARATOR

spironolactone

Intervention Type DRUG

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

control

patients with liver cirrhosis, no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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propranolol

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

Intervention Type DRUG

spironolactone

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Gastrointestinal bleeding in the last 2 weeks
* Encephalopathy \> grade 1
* Acute medical conditions
* Malignant disease
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hvidovre Hospital

Principal Investigators

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Soeren Moeller, MD, DMSc

Role: STUDY_DIRECTOR

Hvidovre University Hospital

Locations

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

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CD-0606-HH-UH-DK

Identifier Type: -

Identifier Source: org_study_id

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