Effect of Betablocker or Aldosterone Antagonist Therapy on Patients With Liver Cirrhosis - Full Text View

Sponsor:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00332904

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 IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Parallel Assignment
Official Title:	Effect of Betablocker or Aldosterone Antagonist Therapy on Oxygenation, Peripheral and Cardiac Hemodynamics and Humoral Systems

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis High Blood Pressure

Drug Information available for: Spironolactone Aldosterone Propranolol hydrochloride Propranolol Dexpropranolol

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 ]

Estimated Enrollment:	30
Study Start Date:	August 2006
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
beta: Active Comparator patients with liver cirrhosis, treated with betablocker	Drug: propranolol tablet 80 mg pr. day in a period of 3 weeks, evt. dose adjustment
spiron: Active Comparator patients with liver cirrhosis, treated with aldosterone antagonist	Drug: spironolactone tablet 200 mg pr. day in 3 weeks, evt. dose adjustment
control: No Intervention 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

Contacts

Contact: Soeren Moeller, MD, DMSc	0045-36322239	soeren.moeller@hh.hosp.dk
Contact: Christine Duemcke, MD	0045-36322274	christine.duemcke@gmx.net

Locations

Denmark
Department of Clinical Physiology and Nuclear Medicine, and Department for Gastrointestinal Medicine, Hvidovre Hospital	Recruiting
Hvidovre, Denmark, 2650
Contact: Christine Duemcke, MD 0045-36322274 christine.duemcke@gmx.net
Sub-Investigator: Aleksander Krag, MD
Sub-Investigator: Flemming Bendtsen, MD, DMSc
Principal Investigator: Christine Duemcke, MD
Sub-Investigator: Soeren Moeller, MD, DMsc
Sub-Investigator: Lise Hobolth, MD

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

Study Director:

Soeren Moeller, MD, DMSc

Hvidovre Hospital

More Information

No publications provided

Responsible Party:	Hvidovre Hospital ( Christine Duemcke, MD )
Study ID Numbers:	CD-0606-HH-UH-DK
Study First Received:	May 31, 2006
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00332904 History of Changes
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:

Vasodilator Agents
Liver Diseases
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Fibrosis
Hormone Antagonists
Diuretics
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Liver Cirrhosis
Hypertension, Portal
Pathologic Processes
Propranolol

Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Spironolactone
Digestive System Diseases
Aldosterone Antagonists
Natriuretic Agents
Adrenergic Antagonists
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009