Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2011-04-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Levosimendan
Levosimendan
At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.
Povidon, waterfree etanol, glucosis 5%
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Sykehuset i Vestfold HF
OTHER
Responsible Party
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Espen Lindholm
Seksjonsoverlege
Principal Investigators
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Espen Lindholm, MD
Role: STUDY_DIRECTOR
Vestfold Hospital trust, Norway
Knut A Kirkebøen, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital - Ullevål, Norway
Mathias Kotyra, Md
Role: PRINCIPAL_INVESTIGATOR
Mölndal hospital, Sweden
Anders Nydahl, Phd
Role: PRINCIPAL_INVESTIGATOR
University Hospital Örebro, Sweden
Locations
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Oslo University Hospital - Ullevål
Oslo, , Norway
Vestfold Hospital Trust
Tønsberg, , Norway
Mölndal Hospital
Gothenburg, , Sweden
Universitety Hospital Örebro
Hudiksvall, , Sweden
Countries
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Other Identifiers
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SIMPLE
Identifier Type: -
Identifier Source: org_study_id