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Myocardial Hemodynamic Effects of Levosimendan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585104
First Posted: January 3, 2008
Last Update Posted: May 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Utah
Results First Submitted: February 11, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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.


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



Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00585104     History of Changes
Other Study ID Numbers: 19266
IRB# 00019266
First Submitted: December 21, 2007
First Posted: January 3, 2008
Results First Submitted: February 11, 2010
Results First Posted: June 9, 2010
Last Update Posted: May 21, 2013