Myocardial Hemodynamic Effects of Levosimendan
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|ClinicalTrials.gov Identifier: NCT00585104|
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : June 9, 2010
Last Update Posted : May 21, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: levosimendan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Myocardial Hemodynamic Effects of Levosimendan|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
All randomized patients receive drug.
Other Name: Simdax
- Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter. [ Time Frame: From baseline to 30-minutes after levosimendan started. ]Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585104
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Andrew Michaels, MD||University of Utah|