Levosimendan in High Risk Heart Valve Surgery

Kuopio University Hospital

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Drug: placebo; Drug: levosimendan

Study type: Interventional

Funder types: Other

Identifiers

NCT00154115

KUH5070178

106/2004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

• Clinical signs of cardiac insufficiency

Exclusion criteria

• Endocarditis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Levosimendan

Treatment:

Drug: levosimendan

2

Placebo Comparator group

Treatment:

Drug: placebo