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

Phase 4

• Conditions: Liver Cirrhosis; Portal Hypertension
• Interventions: Drug: propranolol; Drug: spironolactone

• Registration Number: NCT00332904
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Study First Submitted: 2006-05-31
• Study First Submitted QC: 2006-05-31
• Study First Posted: 2006-06-02
• Study Start: 2006-08
• Primary Completion: 2008-07
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-03
• Last Update Posted: 2010-06-04
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
beta	propranolol	patients with liver cirrhosis, treated with betablocker
spiron	spironolactone	patients with liver cirrhosis, treated with aldosterone antagonist

Primary Outcome Measures

Name	Time	Method
effect of treatment on hemodynamic and cardiac parameters	3 weeks

Trial Locations

Locations (1)

Department of Clinical Physiology and Nuclear Medicine, and Department for Gastrointestinal Medicine, Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark