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Levosimendan in High Risk Heart Valve Surgery

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
levosimendan
placebo
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, levosimendan, cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Eligible for cardiac valve or combined CABG and cardiac valve surgery: Clinical signs of cardiac insufficiency Exclusion Criteria: Endocarditis

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Levosimendan

Outcomes

Primary Outcome Measures

Heart failure necessitating inotropic drug administering after heart valve surgery

Secondary Outcome Measures

Hospital morbidity and mortality
Postoperative mortality at six months

Full Information

First Posted
September 7, 2005
Last Updated
January 20, 2009
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00154115
Brief Title
Levosimendan in High Risk Heart Valve Surgery
Official Title
Efficacy of Levosimendan in Cardiac Failure After Heart Valve Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kuopio University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, levosimendan, cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Levosimendan
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
levosimendan
Intervention Description
Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Heart failure necessitating inotropic drug administering after heart valve surgery
Time Frame
Postoperative hospital period
Secondary Outcome Measure Information:
Title
Hospital morbidity and mortality
Time Frame
Postoperative hospital period
Title
Postoperative mortality at six months
Time Frame
Six months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible for cardiac valve or combined CABG and cardiac valve surgery: Clinical signs of cardiac insufficiency Exclusion Criteria: Endocarditis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasi K Lahtinen, MD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70210
Country
Finland

12. IPD Sharing Statement

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Levosimendan in High Risk Heart Valve Surgery

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