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Completed

NCT Number: NCT00154115

Levosimendan in High Risk Heart Valve Surgery

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kuopio University Hospital

Kuopio, 70210, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Clinical signs of cardiac insufficiency

Exclusion criteria

  • Endocarditis

Treatment and study plan

Levosimendan

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  1. Heart failure necessitating inotropic drug administering after heart valve surgery

    Time frame: Postoperative hospital period

Secondary outcomes

  1. Hospital morbidity and mortality

    Time frame: Postoperative hospital period

  2. Postoperative mortality at six months

    Time frame: Six months postoperatively

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Official study title

Efficacy of Levosimendan in Cardiac Failure After Heart Valve Surgery

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2005
Registry last updated
Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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