Levosimendan in High Risk Heart Valve Surgery

Phase 4

Completed

• Conditions: Heart Failure
• Interventions: Drug: placebo; Drug: levosimendan

• Registration Number: NCT00154115
• Lead Sponsor: Kuopio University Hospital

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-20
• Last Update Posted: 2009-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

• Clinical signs of cardiac insufficiency

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Exclusion Criteria

• Endocarditis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	levosimendan	Levosimendan

Primary Outcome Measures

Name	Time	Method
Heart failure necessitating inotropic drug administering after heart valve surgery	Postoperative hospital period

Secondary Outcome Measures

Name	Time	Method
Hospital morbidity and mortality	Postoperative hospital period
Postoperative mortality at six months	Six months postoperatively

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland