Official Title: “Effect of Betablocker or Aldosterone Antagonist Therapy on Oxygenation, Peripheral and Cardiac Hemodynamics and Humoral Systems”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Parallel Assignment

Study Primary Completion Date: July 2008

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: beta
  • patients with liver cirrhosis, treated with betablocker
• Active Comparator: spiron
  • patients with liver cirrhosis, treated with aldosterone antagonist
• No Intervention: control
  • patients with liver cirrhosis, no treatment

Primary Measures

• effect of treatment on hemodynamic and cardiac parameters
  • Time Frame: 3 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hvidovre University Hospital

Overall Clinical Trial Officials and Contacts

Soeren Moeller, MD, DMSc Study Director Hvidovre Hospital  

Overall Contact: Soeren Moeller, MD, DMSc 0045-36322239 soeren.moeller@hh.hosp.dk

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00332904

Study ID Number: CD-0606-HH-UH-DK

ClinicalTrials.gov Identifier: NCT00332904

Health Authority: Denmark: National Board of Health