Levosimendan in High Risk 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy of Levosimendan in Cardiac Failure After Heart Valve Surgery|
- Heart failure necessitating inotropic drug administering after heart valve surgery [ Time Frame: Postoperative hospital period ] [ Designated as safety issue: Yes ]
- Hospital morbidity and mortality [ Time Frame: Postoperative hospital period ] [ Designated as safety issue: Yes ]
- Postoperative mortality at six months [ Time Frame: Six months postoperatively ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours
|Placebo Comparator: 2||
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.