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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Hvidovre University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00332904
First Posted: June 2, 2006
Last Update Posted: June 4, 2010
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.
Information provided by:
Hvidovre University Hospital
  Purpose
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
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

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 ]

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.

  Eligibility

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
Criteria

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
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


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

Responsible Party: Christine Duemcke, MD, Hvidovre Hospital
ClinicalTrials.gov Identifier: NCT00332904     History of Changes
Other Study ID Numbers: CD-0606-HH-UH-DK
First Submitted: May 31, 2006
First Posted: June 2, 2006
Last Update Posted: June 4, 2010
Last Verified: June 2010

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

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Hypertension, Portal
Pathologic Processes
Liver Diseases
Digestive System Diseases
Propranolol
Adrenergic beta-Antagonists
Spironolactone
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
Diuretics
Natriuretic Agents