Preoperative Levosimendan and Heart Failure

• Status: Withdrawn
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sykehuset i Vestfold HF
• Collaborator: Orion Corporation, Orion Pharma
• Treatments: Simendan

Criteria

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)