A Phase 4 interventional study of levosimendan and placebo in Heart Failure, sponsored by Kuopio University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-01-21.
Sponsored by Kuopio University Hospital · Phase 4, Interventional, and Treatment
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.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's planned enrollment of 200 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Kuopio University Hospital is the lead sponsor of 135 studies on the registry; 24 are open to participants now.
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Eligible for cardiac valve or combined CABG and cardiac valve surgery:
Exclusion Criteria:
Levosimendan
Drug: levosimendan
Drug: placebo
Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours
Placebo
Heart failure necessitating inotropic drug administering after heart valve surgery
Time frame: Postoperative hospital period
Hospital morbidity and mortality
Time frame: Postoperative hospital period
Postoperative mortality at six months
Time frame: Six months postoperatively
This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Simendan