Levosimendan in High Risk Heart Valve Surgery

Efficacy of Levosimendan in Cardiac Failure After Heart Valve Surgery

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154115

Enrollment

200

Registered

2005-09-12

Start date

2005-03-31

Completion date

2008-12-31

Last updated

2009-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, levosimendan, cardiac surgery

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.

Interventions

DRUGlevosimendan

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

DRUGplacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Eligible for cardiac valve or combined CABG and cardiac valve surgery: * Clinical signs of cardiac insufficiency

Exclusion criteria

* Endocarditis

Design outcomes

Primary

Measure	Time frame
Heart failure necessitating inotropic drug administering after heart valve surgery	Postoperative hospital period

Secondary

Measure	Time frame
Hospital morbidity and mortality	Postoperative hospital period
Postoperative mortality at six months	Six months postoperatively

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026