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

Hvidovre University Hospital

Status and phase: Unknown; Phase 4

Conditions: Portal Hypertension; Liver Cirrhosis

Treatments: Drug: spironolactone; Drug: propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT00332904

CD-0606-HH-UH-DK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

beta

Active Comparator group

Description:

patients with liver cirrhosis, treated with betablocker

Treatment:

Drug: propranolol

spiron

Active Comparator group

Description:

patients with liver cirrhosis, treated with aldosterone antagonist

Treatment:

Drug: spironolactone

control

No Intervention group

Description:

patients with liver cirrhosis, no treatment