Preoperative Levosimendan and Heart Failure

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

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

Conditions
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Heart Failure, Hip Fracture

Intervention / Treatment
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* Drug: Levosimendan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levosimendan<br> | Drug: Levosimendan<br>* At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.<br>* Other names: ATC-nr.: C01C X08;|
| Placebo Comparator: Povidon, waterfree etanol, glucosis 5%<br> | Drug: Levosimendan<br>* At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.<br>* Other names: ATC-nr.: C01C X08;Drug: Placebo<br>* ml/kg/hours - same infusion rate as active comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heartfailure - Highest NT-proBNP-value the first 7 days after surgery |  | NT-proBNP 6 hours postoperative, 24 hours postoperative, 48 h postoperative, 72 h postoperative, 96 h postoperative, 120 h postoperative, 144 h postoperative and 168 h postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of hospitalization |  | Hospital stay - number of days patients are hospitalized | 
| Use of inotropes (dopamine, Norepinephrine)during postoperative unit stay. Mg/microgram |  | After 16-18 hours, after 48 hours and every 24 hours if still in the PO-Unit | 
| Mortality | Visits or patients record | 30 days | 
| Ischemia | Continous ECG first 24 hours an ECG every second day | 7 days postoperative | 
| Myocardial necrosis | Troponin taken every day postoperative | 7 days postoperative |