Levosimendan in High Risk Heart Valve Surgery

Efficacy of Levosimendan in Cardiac Failure After Heart Valve Surgery

Prospective, randomized, double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery.

Study hypothesis: Levosimendan diminishes the need for adrenergic inotropic drugs and morbidity and may improve survival after heart valve surgery.

200 patients are prospectively randomized in a double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. Levosimendan/placebo is administered as 24 hour continuous infusion beginning after anesthesia induction. Primary endpoint being adrenergic inotrope need after cardiopulmonary bypass and secondary endpoints hospital and 6-month mortality and major organ failure.

Inclusion Criteria:

Eligible for cardiac valve or combined CABG and cardiac valve surgery:

• Clinical signs of cardiac insufficiency

Exclusion Criteria:

• Endocarditis