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

Effect of Betablocker or Aldosterone Antagonist Therapy on Oxygenation, Peripheral and Cardiac Hemodynamics and Humoral Systems

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00332904

Acronym

PEKASYS

Enrollment

Registered

2006-06-02

Start date

2006-08-31

Completion date

2010-12-31

Last updated

2010-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Portal Hypertension

Keywords

betablocker, aldosterone antagonist, peripheral haemodynamics, cardiac haemodynamics, oxygenation

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.

Detailed description

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.

Interventions

DRUGpropranolol

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

DRUGspironolactone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
effect of treatment on hemodynamic and cardiac parameters	3 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026