NCT00154115

Levosimendan in High Risk Heart Valve Surgery

Efficacy of Levosimendan in Cardiac Failure After Heart Valve Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Kuopio University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	levosimendan	Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours
DRUG	placebo	Placebo

Timeline

• Start date: 2005-03-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2005-09-12
• Last updated: 2009-01-21

Locations

1 site across 1 country: Finland