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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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


Condition Intervention Phase
Heart Failure
Hip Fracture
 Drug: Levosimendan
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Levosimendan in Patients With Heart Failure Undergoing Elective Noncardiac Surgery: A Randomized, Placebocontrolled Trial. SIMPLE Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sykehuset i Vestfold HF:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levosimendan 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
Placebo Comparator: Povidon, waterfree etanol, glucosis 5% 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022983

Locations
Norway
Oslo University Hospital - Ullevål
Oslo, Norway
Vestfold Hospital Trust
Tonsberg, Norway, 3103
Sweden
Mölndal Hospital
Gothenburg, Sweden
Universitety Hospital Örebro
Hudiksvall, Sweden
Sponsors and Collaborators
Sykehuset i Vestfold HF
Orion Corporation, Orion Pharma
Investigators
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
  More Information

No publications provided

Responsible Party: Espen Lindholm, Seksjonsoverlege, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT01022983     History of Changes
Other Study ID Numbers: SIMPLE
Study First Received: November 24, 2009
Last Updated: December 12, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority
Norway: Norwegian Institute of Public Health
Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Heart Failure
Hip Fractures
Heart Diseases
Cardiovascular Diseases
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Simendan
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013