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Clinical Trial Name - Levosimendan in High Risk Heart Valve Surgery
| Original Study ID : KUH5070178 |
| Secondary ID : 106/2004 |
| NCT ID : NCT00154115 |
| Brief Title : Levosimendan in High Risk Heart Valve Surgery |
| Official Title : Efficacy of Levosimendan in Cardiac Failure After Heart Valve 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. |
| Source : Kuopio University Hospital |
| 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. |
| Overall Status : Completed |
| Start Date : March 2005 |
| End Date : December 2008 |
| Completion Date : December 2008 |
| Official Title : Phase 4 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Enrollment : 200 |
| Verification Date : January 2009 |
| First Received Date : September 7, 2005 |
| Trial Eligibility |
| Criteria : Inclusion Criteria: Eligible for cardiac valve or combined CABG and cardiac valve surgery: - Clinical signs of cardiac insufficiency Exclusion Criteria: - Endocarditis |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Kuopio University Hospital |
| City : Kuopio |
| Zip Code : 70210 |
| Country : Finland |
| OutComes |
| Primary OutComes |
| Measure : Heart failure necessitating inotropic drug administering after heart valve surgery |
| Time Frame : Postoperative hospital period |
| Safety issue : Yes |
| Secondary OutComes |
| Measure : Hospital morbidity and mortality |
| Time Frame : Postoperative hospital period |
| Safety issue : Yes |
| Measure : Postoperative mortality at six months |
| Time Frame : Six months postoperatively |
| Safety issue : Yes |
| Interventions |
| Type : Drug |
| Name : levosimendan |
| Description : Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours |
| Type : Drug |
| Name : placebo |
| Description : Placebo |
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