Preoperative Levosimendan and Heart Failure (PELS)

This study has been withdrawn prior to enrollment.
(Not finding patients for including)
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Espen Lindholm, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier:
NCT01022983
First received: November 24, 2009
Last updated: December 12, 2012
Last verified: December 2012

November 24, 2009
December 12, 2012
April 2011
December 2012   (final data collection date for primary outcome measure)
Heartfailure - Highest NT-proBNP-value the first 7 days after surgery [ Time Frame: 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 ] [ Designated as safety issue: No ]
Heartfailure - Highest NT-proBNP-value the first 7 days after surgery [ Time Frame: NT-proBNP 30 minutes postoperative, 16-18 hours postoperative, 48 h postoperative, 72 h postoperative, 96 h postoperative, 120 h postoperative, 144 h postoperative and 168 h postoperative ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01022983 on ClinicalTrials.gov Archive Site
  • Days of hospitalization [ Time Frame: Hospital stay - number of days patients are hospitalized ] [ Designated as safety issue: No ]
  • Use of inotropes (dopamine, Norepinephrine)during postoperative unit stay. Mg/microgram [ Time Frame: After 16-18 hours, after 48 hours and every 24 hours if still in the PO-Unit ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Visits or patients record
  • Ischemia [ Time Frame: 7 days postoperative ] [ Designated as safety issue: No ]
    Continous ECG first 24 hours an ECG every second day
  • Myocardial necrosis [ Time Frame: 7 days postoperative ] [ Designated as safety issue: No ]
    Troponin taken every day postoperative
  • Days of hospitalization [ Time Frame: Hospital stay - number of days patients are hospitalized ] [ Designated as safety issue: No ]
  • Use of inotropes (dopamine, Norepinephrine)during postoperative unit stay. Mg/microgram [ Time Frame: After 16-18 hours, after 48 hours and every 24 hours if still in the PO-Unit ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Preoperative Levosimendan and Heart Failure
Preoperative Levosimendan in Patients With Heart Failure Undergoing Elective Noncardiac Surgery: A Randomized, Placebocontrolled Trial. SIMPLE Study

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Failure
  • Hip Fracture
  • Drug: Levosimendan
    At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.
    Other Names:
    • Simdax
    • ATC-nr.: C01C X08
  • Drug: Placebo
    ml/kg/hours - same infusion rate as active comparator
  • Active Comparator: Levosimendan
    Intervention: Drug: Levosimendan
  • Placebo Comparator: Povidon, waterfree etanol, glucosis 5%
    Interventions:
    • Drug: Levosimendan
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
December 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway,   Sweden
 
NCT01022983
SIMPLE
Yes
Espen Lindholm, Sykehuset i Vestfold HF
Sykehuset i Vestfold HF
Orion Corporation, Orion Pharma
Study Director: Espen Lindholm, MD Vestfold Hospital trust, Norway
Principal Investigator: Knut A Kirkebøen, PhD Oslo University Hospital - Ullevål, Norway
Principal Investigator: Mathias Kotyra, Md Mölndal hospital, Sweden
Principal Investigator: Anders Nydahl, Phd University Hospital Örebro, Sweden
Sykehuset i Vestfold HF
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP