Overview

This trial is active, not recruiting.

Conditions liver cirrhosis, portal hypertension
Treatments propranolol, spironolactone
Phase phase 4
Sponsor Hvidovre University Hospital
Start date August 2006
End date July 2008
Trial size 22 participants
Trial identifier NCT00332904, CD-0606-HH-UH-DK

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
patients with liver cirrhosis, treated with betablocker
propranolol
tablet 80 mg pr. day in a period of 3 weeks, evt. dose adjustment
(Active Comparator)
patients with liver cirrhosis, treated with aldosterone antagonist
spironolactone
tablet 200 mg pr. day in 3 weeks, evt. dose adjustment
(No Intervention)
patients with liver cirrhosis, no treatment

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Effect of Betablocker or Aldosterone Antagonist Therapy on Oxygenation, Peripheral and Cardiac Hemodynamics and Humoral Systems
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by Hvidovre University Hospital.