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

    Phase 4
  • Study Type

  • Status

  • Intervention/Treatment

    levosimendan ...
  • Study Participants

The purpose of this study is to investigate the safety and efficacy of Levosimendan given preoperative to patients with heart failure undergoing noncardiac surgery.
Study Started
Apr 30
Primary Completion
Dec 31
Study Completion
Dec 31
Last Update
Dec 17

Drug Levosimendan

At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.

  • Other names: Simdax, ATC-nr.: C01C X08

Drug Placebo

ml/kg/hours - same infusion rate as active comparator

Levosimendan Active Comparator

Povidon, waterfree etanol, glucosis 5% Placebo 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
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
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)
No Results Posted