Preoperative Levosimendan and Heart Failure (PELS)

Sykehuset i Vestfold HF

Status and phase: Withdrawn; Phase 4

Conditions: Hip Fracture; Heart Failure

Treatments: Drug: Placebo; Drug: Levosimendan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01022983

SIMPLE

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Levosimendan

Active Comparator group

Treatment:

Drug: Levosimendan

Povidon, waterfree etanol, glucosis 5%

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Levosimendan