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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Liver Cirrhosis, Portal Hypertension

Intervention / Treatment
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* Drug: propranolol
* Drug: spironolactone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: beta<br>patients with liver cirrhosis, treated with betablocker | Drug: propranolol<br>* tablet 80 mg pr. day in a period of 3 weeks, evt. dose adjustment<br>|
| Active Comparator: spiron<br>patients with liver cirrhosis, treated with aldosterone antagonist | Drug: spironolactone<br>* tablet 200 mg pr. day in 3 weeks, evt. dose adjustment<br>|
| No Intervention: control<br>patients with liver cirrhosis, no treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of treatment on hemodynamic and cardiac parameters |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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betablocker, aldosterone antagonist, peripheral haemodynamics, cardiac haemodynamics, oxygenation