NCT01188369

Brief Summary

This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

December 3, 2018

Completed
Last Updated

December 3, 2018

Status Verified

August 1, 2012

Enrollment Period

2.5 years

First QC Date

August 10, 2010

Results QC Date

May 11, 2018

Last Update Submit

May 11, 2018

Conditions

Diastolic DysfunctionLeft Ventricular Hypertrophy

Keywords

levosimendanheart failureinotropicsdiastolic dysfunctionleft ventricular hypertrophyaortic valve stenosis

Outcome Measures

Primary Outcomes (1)

  • E/E'(Unitless)

    Ration between early transmitral flow (E) and mitral annular tissue velocity(E'). This ratio is an echocardiographic index of diastolic function

    4 hours before operation until 21 hour after operation

Secondary Outcomes (77)

  • Isovolumetric Relaxation Time (IVRT) (s)

    4 hours before surgery until 1 hour before operation

  • Ejection Fraction (Per Cent)

    At start of operation until end of operation, approximately 3 hours

  • Cardiac Index (l/Min/m2)

    4 hours before operation until 1 hour before operation

  • Central Venous Pressure (mmHg)

    4 hours before operation until 1 hours before operation

  • Pulmonary Artery Pressures (mmHg)

    4 hours before operation until 1 hour before operation

  • +72 more secondary outcomes

Study Arms (2)

levosimendan

EXPERIMENTAL

infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation

Drug: levosimendan

Placebo

PLACEBO COMPARATOR

Identical placebo

Drug: placebo drug

Interventions

levosimendanDRUG

Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation.

Also known as: Simdax
levosimendan
placebo drugDRUG

Intravenous infusion, colour identical to levosimendan

Also known as: Placebo
Placebo

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible for aortic valve replacement
  • EF \> 45%
  • Left ventricular posterior wall \> 12mm
  • Sinus rhythm

You may not qualify if:

  • Concomitant bypass operation
  • Severe mitral insufficiency
  • Active endocarditis
  • Insufficient ultrasound opportunity
  • Systolic blood pressure \< 100 mmHg
  • moderate-severe renal failure
  • allergy to levosimendan
  • lack of patient consent Pregnancy or status of lactating
  • Fertile women who do not use relevant anticonception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology

Århus N, Central Jutland, 8200, Denmark

Location

MeSH Terms

Conditions

Hypertrophy, Left VentricularHeart FailureAortic Valve Stenosis

Interventions

Simendan

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsAortic Valve DiseaseHeart Valve DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Peter Juhl-Olsen
Organization
Aarhus University Hospital
peter.juhl-olsen@ki.au.dk
+4578451199

Study Officials

  • Peter Juhl-Olsen, M.D.

    Department of Anaesthesiology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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
SPONSOR

Study Record Dates

First Submitted

August 10, 2010

First Posted

August 25, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 3, 2018

Results First Posted

December 3, 2018

Record last verified: 2012-08

Locations

DK(1)