Status:
TERMINATED
Study of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery
Lead Sponsor:
Emory University
Collaborating Sponsors:
Abbott
Conditions:
Heart Failure
Eligibility:
All Genders
21-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study protocol is to evaluate the blood concentrations of levosimendan when administered at different doses clinically employed during cardiopulmonary bypass or cardiac manipulatio...
Detailed Description
This is a non-randomized trial, and the patients will be assigned to one of three dose groups following cardiopulmonary bypass or prior to manipulation of the heart in the off pump group. A total of 3...
Eligibility Criteria
Inclusion
- At least 21 years of age
- Less than 80 years of age
- ASA Class III-IV
- Scheduled for elective cardiac surgery
- Signed informed consent
- History of heart failure, and/or left ventricular ejection fraction \<50%
Exclusion
- Emergency surgery
- Withdrawal of consent
- Uncontrollable ventricular arrhythmias
- Obstructive cardiomyopathy
- Confirmed pregnancy test for women of child-bearing potential
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00166127
Start Date
May 1 2005
End Date
January 1 2007
Last Update
November 15 2013
Active Locations (1)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322