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Myocardial Hemodynamic Effects of Levosimendan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00585104
First received: December 21, 2007
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
Results First Received: February 11, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Heart Failure
Intervention: Drug: levosimendan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Levosimendan, Compare Heart Function and Metabolism All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.

Participant Flow:   Overall Study
    Levosimendan, Compare Heart Function and Metabolism  
STARTED     10  
COMPLETED     6  
NOT COMPLETED     4  



  Baseline Characteristics
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Reporting Groups
  Description
Levosimendan, Compare Heart Function and Metabolism All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.

Baseline Measures
    Levosimendan, Compare Heart Function and Metabolism  
Number of Participants  
[units: participants]
 		  10  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  59  ± 13.6  
Gender  
[units: participants]
 		 
Female     8  
Male     2  
Region of Enrollment  
[units: participants]
 		 
United States     10  
Left Ventricular End Diastolic Pressure (LVEDP)  
[units: mmHg]
Mean ± Standard Deviation 		  18  ± 7  



  Outcome Measures

1.  Primary:   Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter.   [ Time Frame: From baseline to 30-minutes after levosimendan started. ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Of the ten (10) patients enrolled, only 6 patients completed the study protocol for which we collected data. The data is insufficient to provide a formal summary for publication.  


Results Point of Contact:  
Name/Title: Andrew D. Michaels, MD
Organization: University of Utah Health Sciences Center
phone: (801) 585-5971
e-mail: Andrew.Michaels@hsc.utah.edu


No publications provided


Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00585104     History of Changes
Other Study ID Numbers: 19266, IRB# 00019266
Study First Received: December 21, 2007
Results First Received: February 11, 2010
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board