Preoperative Levosimendan and Heart Failure

Preoperative Levosimendan in Patients With Heart Failure Undergoing Elective Noncardiac Surgery: A Randomized, Placebocontrolled Trial. SIMPLE Study

The purpose of this study is to investigate the safety and efficacy of Levosimendan given preoperative to patients with heart failure undergoing noncardiac surgery.

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)