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

Pharmacokinetics and Pharmacodynamics of Levosimendan During Cardiac Surgery

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.

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 30 patients will be enrolled into this study, 20 off-pump and 10 subjects on pump. Levosimendan is approved in Europe for the treatment of decompensated heart failure. It improved cardiac function without increasing energy demands. The subject's enrollment ends at Day 7 or day of discharge, whichever comes first.

Inclusion Criteria:

• 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 Criteria:

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