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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

Page last updated: October 19, 2009

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