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Trial record 19 of 224 for:    Aldosterone

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.
 
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
Sponsor:
Information provided by:
Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE May 31, 2006
First Posted Date  ICMJE June 2, 2006
Last Update Posted Date June 4, 2010
Study Start Date  ICMJE August 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2007)
effect of treatment on hemodynamic and cardiac parameters [ Time Frame: 3 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00332904 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Betablocker or Aldosterone Antagonist Therapy on Patients With Liver Cirrhosis
Official Title  ICMJE Effect of Betablocker or Aldosterone Antagonist Therapy on Oxygenation, Peripheral and Cardiac Hemodynamics and Humoral Systems
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liver Cirrhosis
  • Portal Hypertension
Intervention  ICMJE
  • Drug: propranolol
    tablet 80 mg pr. day in a period of 3 weeks, evt. dose adjustment
  • Drug: spironolactone
    tablet 200 mg pr. day in 3 weeks, evt. dose adjustment
Study Arms  ICMJE
  • Active Comparator: beta
    patients with liver cirrhosis, treated with betablocker
    Intervention: Drug: propranolol
  • Active Comparator: spiron
    patients with liver cirrhosis, treated with aldosterone antagonist
    Intervention: Drug: spironolactone
  • No Intervention: control
    patients with liver cirrhosis, no treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: June 3, 2010)
22
Original Enrollment  ICMJE
 (submitted: May 31, 2006)
30
Estimated Study Completion Date  ICMJE December 2010
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00332904
Other Study ID Numbers  ICMJE CD-0606-HH-UH-DK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christine Duemcke, MD, Hvidovre Hospital
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Soeren Moeller, MD, DMSc Hvidovre University Hospital
PRS Account Hvidovre University Hospital
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP