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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 31, 2006 | ||||||||
| Last Updated Date | July 18, 2008 | ||||||||
| Start Date ICMJE | August 2006 | ||||||||
| Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
effect of treatment on hemodynamic and cardiac parameters [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
effect of treatment on hemodynamic and cardiac parameters [ Time Frame: 3 weeks ] | ||||||||
| Change History | Complete list of historical versions of study NCT00332904 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Betablocker or Aldosterone Antagonist Therapy on Patients With Liver Cirrhosis | ||||||||
| Official Title ICMJE | Effect of Betablocker or Aldosterone Antagonist Therapy on Oxygenation, Peripheral and Cardiac Hemodynamics and Humoral Systems | ||||||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Open Label, Parallel Assignment | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | August 2008 | ||||||||
| Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00332904 | ||||||||
| Responsible Party | Christine Duemcke, MD, Hvidovre Hospital | ||||||||
| Study ID Numbers ICMJE | CD-0606-HH-UH-DK | ||||||||
| Study Sponsor ICMJE | Hvidovre University Hospital | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Hvidovre University Hospital | ||||||||
| Verification Date | July 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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