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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
  Purpose

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.


Condition Intervention Phase
Heart Failure
 Drug: levosimendan
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Levosimendan in Cardiac Failure After Heart Valve Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kuopio University Hospital:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: March 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: 2 Drug: placebo
Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  • Clinical signs of cardiac insufficiency

Exclusion Criteria:

  • Endocarditis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00154115

Locations
Finland
Kuopio University Hospital
Kuopio, Finland, 70210
Sponsors and Collaborators
Kuopio University Hospital
Investigators
Principal Investigator: Pasi K Lahtinen, MD Kuopio University Hospital
  More Information

No publications provided

Responsible Party: Pasi Lahtinen, MD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00154115     History of Changes
Other Study ID Numbers: KUH5070178, 106/2004
Study First Received: September 7, 2005
Last Updated: January 20, 2009
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Kuopio University Hospital:
heart failure
levosimendan
cardiac surgery

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Simendan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013