Preoperative Levosimendan and Heart Failure

Heart Failure Clinical Trial

— PELS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01022983
• Other study ID #: SIMPLE
• Status: Withdrawn
• Phase: Phase 4
• First received: November 24, 2009
• Last updated: December 12, 2012
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Sykehuset i Vestfold HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Data Protection AuthorityNorway: Norwegian Institute of Public HealthSweden: Regional Ethical Review BoardSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Hip Fracture
• Hip Fractures

Intervention

Drug:
• Levosimendan
At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.
• Placebo
ml/kg/hours - same infusion rate as active comparator

Locations

Country	Name	City	State
Norway	Oslo University Hospital - Ullevål	Oslo
Norway	Vestfold Hospital Trust	Tonsberg
Sweden	Mölndal Hospital	Gothenburg
Sweden	Universitety Hospital Örebro	Hudiksvall

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF	Orion Corporation, Orion Pharma

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Days of hospitalization		Hospital stay - number of days patients are hospitalized	No
Secondary	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	No
Secondary	Mortality	Visits or patients record	30 days	No
Secondary	Ischemia	Continous ECG first 24 hours an ECG every second day	7 days postoperative	No
Secondary	Myocardial necrosis	Troponin taken every day postoperative	7 days postoperative	No