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

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ClinicalTrials.gov Identifier: NCT00332904
Recruitment Status : Unknown
Verified June 2010 by Hvidovre University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 2, 2006
Last Update Posted : June 4, 2010
Information provided by:
Hvidovre University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Portal Hypertension Drug: propranolol Drug: spironolactone Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Betablocker or Aldosterone Antagonist Therapy on Oxygenation, Peripheral and Cardiac Hemodynamics and Humoral Systems
Study Start Date : August 2006
Primary Completion Date : July 2008
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. effect of treatment on hemodynamic and cardiac parameters [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Christine Duemcke, MD, Hvidovre Hospital
ClinicalTrials.gov Identifier: NCT00332904     History of Changes
Other Study ID Numbers: CD-0606-HH-UH-DK
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: June 4, 2010
Last Verified: June 2010

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