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

This study is ongoing, but not recruiting participants.
Information provided by:
Hvidovre University Hospital Identifier:
First received: May 31, 2006
Last updated: June 3, 2010
Last verified: June 2010
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.

Condition Intervention Phase
Liver Cirrhosis
Portal Hypertension
Drug: propranolol
Drug: spironolactone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Betablocker or Aldosterone Antagonist Therapy on Oxygenation, Peripheral and Cardiac Hemodynamics and Humoral Systems

Resource links provided by NLM:

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • effect of treatment on hemodynamic and cardiac parameters [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: August 2006
Estimated Study Completion Date: December 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: beta
patients with liver cirrhosis, treated with betablocker
Drug: propranolol
tablet 80 mg pr. day in a period of 3 weeks, evt. dose adjustment
Active Comparator: spiron
patients with liver cirrhosis, treated with aldosterone antagonist
Drug: spironolactone
tablet 200 mg pr. day in 3 weeks, evt. dose adjustment
No Intervention: control
patients with liver cirrhosis, no treatment

Detailed 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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00332904

Department of Clinical Physiology and Nuclear Medicine, and Department for Gastrointestinal Medicine, Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Study Director: Soeren Moeller, MD, DMSc Hvidovre University Hospital
  More Information

Responsible Party: Christine Duemcke, MD, Hvidovre Hospital Identifier: NCT00332904     History of Changes
Other Study ID Numbers: CD-0606-HH-UH-DK 
Study First Received: May 31, 2006
Last Updated: June 3, 2010
Health Authority: Denmark: National Board of Health

Keywords provided by Hvidovre University Hospital:
aldosterone antagonist
peripheral haemodynamics
cardiac haemodynamics

Additional relevant MeSH terms:
Liver Cirrhosis
Hypertension, Portal
Pathologic Processes
Liver Diseases
Digestive System Diseases
Adrenergic beta-Antagonists
Mineralocorticoid Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Natriuretic Agents processed this record on January 14, 2017