Effect of Betablocker or Aldosterone Antagonist Therapy on Patients With Liver Cirrhosis
Information source: Hvidovre University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Cirrhosis; Portal Hypertension
Intervention: propranolol (Drug); spironolactone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hvidovre University Hospital Official(s) and/or principal investigator(s):
Soeren Moeller, MD, DMSc, Study Director, Affiliation: Hvidovre Hospital
Overall contact:
Soeren Moeller, MD, DMSc, Phone: 0045-36322239, Email: soeren.moeller@hh.hosp.dk
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.
Clinical Details
Official title: Effect of Betablocker or Aldosterone Antagonist Therapy on Oxygenation, Peripheral and Cardiac Hemodynamics and Humoral Systems
Study design: Treatment, Open Label, Parallel Assignment
Primary outcome: effect of treatment on hemodynamic and cardiac parameters
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Soeren Moeller, MD, DMSc, Phone: 0045-36322239, Email: soeren.moeller@hh.hosp.dk
Department of Clinical Physiology and Nuclear Medicine, and Department for Gastrointestinal Medicine, Hvidovre Hospital, Hvidovre 2650, Denmark; Recruiting
Christine Duemcke, MD, Phone: 0045-36322274, Email: christine.duemcke@gmx.net
Aleksander Krag, MD, Sub-Investigator
Flemming Bendtsen, MD, DMSc, Sub-Investigator
Christine Duemcke, MD, Principal Investigator
Soeren Moeller, MD, DMsc, Sub-Investigator
Lise Hobolth, MD, Sub-Investigator
Additional Information
Starting date: August 2006
Ending date: August 2008
Last updated: July 18, 2008
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