Title
Preoperative Levosimendan and Heart Failure
Preoperative Levosimendan in Patients With Heart Failure Undergoing Elective Noncardiac Surgery: A Randomized, Placebocontrolled Trial. SIMPLE Study
Phase
Phase 4Lead Sponsor
Sykehuset i Vestfold HFStudy Type
InterventionalStatus
WithdrawnIndication/Condition
Heart Failure Hip FractureIntervention/Treatment
levosimendan ...Study Participants
0The purpose of this study is to investigate the safety and efficacy of Levosimendan given preoperative to patients with heart failure undergoing noncardiac surgery.
At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.
ml/kg/hours - same infusion rate as active comparator
Inclusion Criteria: Acute surgery. Hip Fracture Patient with cardiac failure (EF < 35%) or known coronary disease At least 2 of 11 comorbidities Patient has to use at least one heart failure medication Symptoms of heart failure NT-proBNP > 2000pg/ml Exclusion Criteria: < 18 years old Participants in other pharmacological study Abuse of medicaments or alcohol Pregnant or breastfeeding women AMI at admission HOCM Serious aortic stenosis (< 1 cm2) Sustained ventricular tachycardia Earlier episodes of "torsades de pointes" Sustained heartbeat > 120/minute Systolic BP < 90 mmHg Surgery planned not before 2 hours of study medication can be infused preoperative Cardiac surgery Dementia S-K < 3 mmol/l Allergy levosimendan Serious liver failure (Known Class C Child-Pugh score) Serious kidney failure (GFR < 30 ml/min.) Prolonged QTc-interval (male QTc > 0,43 s, female QTc > 0,45 s)
