Preoperative Levosimendan and Heart Failure

Phase 4

Withdrawn

• Conditions: Heart Failure; Hip Fracture
• Interventions: Drug: Levosimendan; Drug: Placebo

• Registration Number: NCT01022983
• Lead Sponsor: Sykehuset i Vestfold HF

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Study Start: 2011-04
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-12
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levosimendan	Levosimendan	-
Povidon, waterfree etanol, glucosis 5%	Levosimendan	-
Povidon, waterfree etanol, glucosis 5%	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	30 days	Visits or patients record
Ischemia	7 days postoperative	Continous ECG first 24 hours an ECG every second day
Myocardial necrosis	7 days postoperative	Troponin taken every day postoperative

Trial Locations

Locations (4)

Oslo University Hospital - Ullevål; 🇳🇴 Oslo, Norway

Mölndal Hospital; 🇸🇪 Gothenburg, Sweden

Universitety Hospital Örebro; 🇸🇪 Hudiksvall, Sweden

Vestfold Hospital Trust; 🇳🇴 Tonsberg, Norway