NCT01022983

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_4 heart-failure

Geographic Reach
2 countries

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

1.7 years

First QC Date

November 24, 2009

Last Update Submit

December 12, 2012

Conditions

Heart FailureHip Fracture

Outcome Measures

Primary Outcomes (1)

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

    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 (5)

  • Days of hospitalization

    Hospital stay - number of days patients are hospitalized

  • Use of inotropes (dopamine, Norepinephrine)during postoperative unit stay. Mg/microgram

    After 16-18 hours, after 48 hours and every 24 hours if still in the PO-Unit

  • Mortality

    30 days

  • Ischemia

    7 days postoperative

  • Myocardial necrosis

    7 days postoperative

Study Arms (2)

Levosimendan

ACTIVE COMPARATOR
Drug: Levosimendan

Povidon, waterfree etanol, glucosis 5%

PLACEBO COMPARATOR
Drug: LevosimendanDrug: Placebo

Interventions

LevosimendanDRUG

At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.

Also known as: Simdax, ATC-nr.: C01C X08
LevosimendanPovidon, waterfree etanol, glucosis 5%
PlaceboDRUG

ml/kg/hours - same infusion rate as active comparator

Povidon, waterfree etanol, glucosis 5%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \< 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Oslo University Hospital - Ullevål

Oslo, Norway

Location

Vestfold Hospital Trust

Tønsberg, 3103, Norway

Location

Mölndal Hospital

Gothenburg, Sweden

Location

Universitety Hospital Örebro

Hudiksvall, Sweden

Location

MeSH Terms

Conditions

Heart FailureHip Fractures

Interventions

Simendan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Espen Lindholm, MD

    Vestfold Hospital trust, Norway

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seksjonsoverlege

Study Record Dates

First Submitted

November 24, 2009

First Posted

December 1, 2009

Study Start

April 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

SE(2)NO(2)