Levosimendan in High Risk Heart Valve Surgery

K

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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