Study of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery

Stopped early · Phase 3

Conditions studied: Heart Failure

In brief

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 manipulation during off pump surgery in patients who require the drug for inotropic support (improved heart function) and the associated hemodynamic variables (vital signs). Levosimendan is one of the first agents in a new class of drugs used to treat heart failure and works via a unique mechanism called calcium sensitization, that makes the heart beat more efficiently. Levosimendan also has unique effects on the blood vessels, as well as causing relaxation, an important therapeutic approach of heart failure therapy.

Key facts

Study ID

NCT00166127

Run by

Emory University

People needed

1

Starts

2005-05-01

Expected to finish

2007-01-01

Last updated by the study team

2013-11-15

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• Emergency surgery
• Withdrawal of consent
• Uncontrollable ventricular arrhythmias
• Obstructive cardiomyopathy
• Confirmed pregnancy test for women of child-bearing potential

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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