Levosimendan in High Risk Heart Valve Surgery

January 20, 2009 updated by: Kuopio University Hospital

Efficacy of Levosimendan in Cardiac Failure After 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70210
        • Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

  • Clinical signs of cardiac insufficiency

Exclusion Criteria:

  • Endocarditis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: placebo
Placebo
Experimental: 1
Levosimendan
Drug: levosimendan
Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Heart failure necessitating inotropic drug administering after heart valve surgery
Time Frame: Postoperative hospital period
Postoperative hospital period

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital morbidity and mortality
Time Frame: Postoperative hospital period
Postoperative hospital period
Postoperative mortality at six months
Time Frame: Six months postoperatively
Six months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Investigators

  • Principal Investigator: Pasi K Lahtinen, MD, Kuopio University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 21, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5070178
  • 106/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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