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

Liver Cirrhosis Clinical Trial

— PEKASYS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00332904
• Other study ID #: CD-0606-HH-UH-DK
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 31, 2006
• Last updated: June 3, 2010
• Start date: August 2006
• Est. completion date: December 2010

Study information

• Verified date: June 2010
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Drug:
• propranolol
tablet 80 mg pr. day in a period of 3 weeks, evt. dose adjustment
• spironolactone
tablet 200 mg pr. day in 3 weeks, evt. dose adjustment

Locations

Country	Name	City	State
Denmark	Department of Clinical Physiology and Nuclear Medicine, and Department for Gastrointestinal Medicine, Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of treatment on hemodynamic and cardiac parameters		3 weeks	Yes