COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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.

Layout table for study information
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
Actual Primary Completion Date : July 2008
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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 identifier (NCT number): NCT00332904

Layout table for location information
Department of Clinical Physiology and Nuclear Medicine, and Department for Gastrointestinal Medicine, Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Layout table for investigator information
Study Director: Soeren Moeller, MD, DMSc Hvidovre University Hospital

Layout table for additonal information
Responsible Party: Christine Duemcke, MD, Hvidovre Hospital Identifier: NCT00332904    
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:
Layout table for 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