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Preoperative Levosimendan and Heart Failure (PELS)

Primary Purpose

Heart Failure, Hip Fracture

Status
Withdrawn
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Levosimendan
Placebo
Sponsored by
Sykehuset i Vestfold HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Oslo University Hospital - Ullevål
  • Vestfold Hospital Trust
  • Mölndal Hospital
  • Universitety Hospital Örebro

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Levosimendan

Povidon, waterfree etanol, glucosis 5%

Arm Description

Outcomes

Primary Outcome Measures

Heartfailure - Highest NT-proBNP-value the first 7 days after surgery

Secondary Outcome Measures

Days of hospitalization
Use of inotropes (dopamine, Norepinephrine)during postoperative unit stay. Mg/microgram
Mortality
Visits or patients record
Ischemia
Continous ECG first 24 hours an ECG every second day
Myocardial necrosis
Troponin taken every day postoperative

Full Information

First Posted
November 24, 2009
Last Updated
December 12, 2012
Sponsor
Sykehuset i Vestfold HF
Collaborators
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01022983
Brief Title
Preoperative Levosimendan and Heart Failure
Acronym
PELS
Official Title
Preoperative Levosimendan in Patients With Heart Failure Undergoing Elective Noncardiac Surgery: A Randomized, Placebocontrolled Trial. SIMPLE Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Not finding patients for including
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset i Vestfold HF
Collaborators
Orion Corporation, Orion Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Hip Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levosimendan
Arm Type
Active Comparator
Arm Title
Povidon, waterfree etanol, glucosis 5%
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Levosimendan
Other Intervention Name(s)
Simdax, ATC-nr.: C01C X08
Intervention Description
At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
ml/kg/hours - same infusion rate as active comparator
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Days of hospitalization
Time Frame
Hospital stay - number of days patients are hospitalized
Title
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
Title
Mortality
Description
Visits or patients record
Time Frame
30 days
Title
Ischemia
Description
Continous ECG first 24 hours an ECG every second day
Time Frame
7 days postoperative
Title
Myocardial necrosis
Description
Troponin taken every day postoperative
Time Frame
7 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Espen Lindholm, MD
Organizational Affiliation
Vestfold Hospital trust, Norway
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Knut A Kirkebøen, PhD
Organizational Affiliation
Oslo University Hospital - Ullevål, Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mathias Kotyra, Md
Organizational Affiliation
Mölndal hospital, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anders Nydahl, Phd
Organizational Affiliation
University Hospital Örebro, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital - Ullevål
City
Oslo
Country
Norway
Facility Name
Vestfold Hospital Trust
City
Tonsberg
ZIP/Postal Code
3103
Country
Norway
Facility Name
Mölndal Hospital
City
Gothenburg
Country
Sweden
Facility Name
Universitety Hospital Örebro
City
Hudiksvall
Country
Sweden

12. IPD Sharing Statement

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Preoperative Levosimendan and Heart Failure

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