Levosimendan in High Risk Heart Valve Surgery

This study has been completed.

Sponsor:

Information provided by:

Kuopio University Hospital

ClinicalTrials.gov Identifier:

NCT00154115

First received: September 7, 2005

Last updated: January 20, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

January 20, 2009

Start Date ^ICMJE

March 2005

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Heart failure necessitating inotropic drug administering after heart valve surgery [ Time Frame: Postoperative hospital period ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Heart failure necessitating inotropic drug administering after heart valve surgery

Change History

Complete list of historical versions of study NCT00154115 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hospital morbidity and mortality [ Time Frame: Postoperative hospital period ] [ Designated as safety issue: Yes ]
Postoperative mortality at six months [ Time Frame: Six months postoperatively ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Hospital morbidity and mortality
Postoperative mortality at six months postoperatively

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Levosimendan in High Risk Heart Valve Surgery

Official Title ^ICMJE

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

Drug: levosimendan
Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours
Drug: placebo
Placebo

Study Arm (s)

Experimental: 1
Levosimendan

Intervention: Drug: levosimendan
Placebo Comparator: 2
Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

200

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Clinical signs of cardiac insufficiency

Exclusion Criteria:

Endocarditis

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT00154115

Other Study ID Numbers ^ICMJE

KUH5070178, 106/2004

Has Data Monitoring Committee

Yes

Responsible Party

Pasi Lahtinen, MD, Kuopio University Hospital

Study Sponsor ^ICMJE

Kuopio University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Pasi K Lahtinen, MD

Kuopio University Hospital

Information Provided By

Kuopio University Hospital

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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