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:	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:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

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 ]

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 February 12, 2012