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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 because the information has not been verified recently.
Verified June 2010 by Hvidovre University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00332904
First received: May 31, 2006
Last updated: June 3, 2010
Last verified: June 2010
History of Changes
  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
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital
  More Information

No publications provided

Responsible Party: Christine Duemcke, MD, Hvidovre Hospital
ClinicalTrials.gov 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:
betablocker
aldosterone antagonist
peripheral haemodynamics
cardiac haemodynamics
oxygenation

Additional relevant MeSH terms:
Hypertension
Hypertension, Portal
Liver Cirrhosis
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Pathologic Processes
Adrenergic beta-Antagonists
Propranolol
Aldosterone Antagonists
Spironolactone
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on May 16, 2013