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

Primary Purpose

Liver Cirrhosis, Portal Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
propranolol
spironolactone
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring betablocker, aldosterone antagonist, peripheral haemodynamics, cardiac haemodynamics, oxygenation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Clinical Physiology and Nuclear Medicine, and Department for Gastrointestinal Medicine, Hvidovre Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

beta

spiron

control

Arm Description

patients with liver cirrhosis, treated with betablocker

patients with liver cirrhosis, treated with aldosterone antagonist

patients with liver cirrhosis, no treatment

Outcomes

Primary Outcome Measures

effect of treatment on hemodynamic and cardiac parameters

Secondary Outcome Measures

Full Information

First Posted
May 31, 2006
Last Updated
June 3, 2010
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00332904
Brief Title
Effect of Betablocker or Aldosterone Antagonist Therapy on Patients With Liver Cirrhosis
Acronym
PEKASYS
Official Title
Effect of Betablocker or Aldosterone Antagonist Therapy on Oxygenation, Peripheral and Cardiac Hemodynamics and Humoral Systems
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Portal Hypertension
Keywords
betablocker, aldosterone antagonist, peripheral haemodynamics, cardiac haemodynamics, oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
beta
Arm Type
Active Comparator
Arm Description
patients with liver cirrhosis, treated with betablocker
Arm Title
spiron
Arm Type
Active Comparator
Arm Description
patients with liver cirrhosis, treated with aldosterone antagonist
Arm Title
control
Arm Type
No Intervention
Arm Description
patients with liver cirrhosis, no treatment
Intervention Type
Drug
Intervention Name(s)
propranolol
Intervention Description
tablet 80 mg pr. day in a period of 3 weeks, evt. dose adjustment
Intervention Type
Drug
Intervention Name(s)
spironolactone
Intervention Description
tablet 200 mg pr. day in 3 weeks, evt. dose adjustment
Primary Outcome Measure Information:
Title
effect of treatment on hemodynamic and cardiac parameters
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soeren Moeller, MD, DMSc
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Clinical Physiology and Nuclear Medicine, and Department for Gastrointestinal Medicine, Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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