Clinical trial NCT01022983: Preoperative Levosimendan and Heart Failure
Official title: Preoperative Levosimendan in Patients With Heart Failure Undergoing Elective Noncardiac Surgery: A Randomized, Placebocontrolled Trial. SIMPLE Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Heart Failure
Hip Fracture
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2009-12-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Heartfailure - Highest NT-proBNP-value the first 7 days after surgery
timeFrame: 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 outcomes:
measure: Days of hospitalization
timeFrame: Hospital stay - number of days patients are hospitalized
measure: Use of inotropes (dopamine, Norepinephrine)during postoperative unit stay. Mg/microgram
timeFrame: After 16-18 hours, after 48 hours and every 24 hours if still in the PO-Unit
measure: Mortality
timeFrame: 30 days
measure: Ischemia
timeFrame: 7 days postoperative
measure: Myocardial necrosis
timeFrame: 7 days postoperative
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital - Ullevål
city: Tonsberg
country: Norway
facility: Vestfold Hospital Trust
city: Gothenburg
country: Sweden
facility: Mölndal Hospital
city: Hudiksvall
country: Sweden
facility: Universitety Hospital Örebro
Study officials:
affiliation: Vestfold Hospital trust, Norway
name: Espen Lindholm, MD
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital - Ullevål, Norway
name: Knut A Kirkebøen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mölndal hospital, Sweden
name: Mathias Kotyra, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Örebro, Sweden
name: Anders Nydahl, Phd
role: PRINCIPAL_INVESTIGATOR
References: