Levosimendan in High Risk Heart Valve Surgery | NCT00154115

Studies
Levosimendan in High Risk Heart Valve Surgery

NCT00154115

Sponsor

Kuopio University Hospital

Status

Completed

Last Update Posted

Jan 21, 2009Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Heart Failure

Interventions

levosimendan
placebo

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
106/2004

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2009

Last Update Posted Date

Jan 21, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective, randomized, double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery.

Study hypothesis: Levosimendan diminishes the need for adrenergic inotropic drugs and morbidity and may improve survival after heart valve surgery.

Detailed Description

200 patients are prospectively randomized in a double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. Levosimendan/placebo is administered as 24 hour continuous infusion beginning after anesthesia induction. Primary endpoint being adrenergic inotrope need after cardiopulmonary bypass and secondary endpoints hospital and 6-month mortality and major organ failure.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Levosimendan	Drug: levosimendan
2	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
levosimendan	Drug	Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart failure necessitating inotropic drug administering after heart valve surgery		Postoperative hospital period

Secondary Outcomes

Measure	Description	Time Frame
Hospital morbidity and mortality		Postoperative hospital period
Postoperative mortality at six months		Six months postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible for cardiac valve or combined CABG and cardiac valve surgery:

Clinical signs of cardiac insufficiency

Exclusion Criteria:

Endocarditis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pasi K Lahtinen, MD	Kuopio University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University Hospital		Kuopio		70210	Finland

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077464	Simendan

Ancestor Terms

ID	Term
D006835	Hydrazones
D006834	Hydrazines
D009930	Organic Chemicals
D011724	Pyridazines

Browse Leaves

Not provided

Browse Branches

Not provided