Levosimendan in High Risk Heart Valve Surgery

NCT ID: NCT00154115

Last Updated: 2009-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Levosimendan

Group Type EXPERIMENTAL

levosimendan

Intervention Type DRUG

Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo

Interventions

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levosimendan

Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours

Intervention Type DRUG

placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

* Clinical signs of cardiac insufficiency

Exclusion Criteria

* Endocarditis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kuopio University Hospital

Principal Investigators

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Pasi K Lahtinen, MD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Locations

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Kuopio University Hospital

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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106/2004

Identifier Type: -

Identifier Source: secondary_id

KUH5070178

Identifier Type: -

Identifier Source: org_study_id

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