Myocardial Hemodynamic Effects of Levosimendan
This study will test the hypothesis that mechanical efficiency as measured by pressure-volume loop assessment should improve during short-term treatment with intravenous levosimendan.
Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which has been shown to have beneficial hemodynamic effects in patients with decompensated congestive heart failure (CHF). Levosimendan is a new calcium sensitizer that binds to troponin C. This agent is approved in Europe for treatment of heart failure patients. In the United States, this agent is currently under phase III investigation for intravenous treatment of patients with acutely decompensated HF who have dyspnea at rest or with minimal activity. Levosimendan has been studied in these patients with acute HF and is considered experimental in the United States for this population.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Myocardial Hemodynamic Effects of Levosimendan|
- Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter. [ Time Frame: From baseline to 30-minutes after levosimendan started. ] [ Designated as safety issue: No ]Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis.
|Study Start Date:||September 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
All randomized patients receive drug.
Other Name: Simdax
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585104
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Andrew Michaels, MD||University of Utah|