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The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting (CABG) Surgery

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ClinicalTrials.gov Identifier: NCT01210976
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : September 21, 2011
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

Brief Summary:

Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass grafting (CABG) are at risk of left ventricular dysfunction. The aim of the study is to describe the haemodynamic effects of levosimendan in comparison to placebo in patients undergoing elective aortic valve replacement (AVR) together with coronary artery bypass grafting (CABG) surgery. The study is randomized, double-blinded, placebo-controlled and will be carried out in Heart Center.

Twenty four patients will be randomized into two groups of 12. The treatment group will receive 24 hour infusion of levosimendan preoperatively where as the placebo group will receive an identical infusion of thiamine coloured glucose. The splanchnic perfusion will be measured by the means of vena hepatica cannulation. CircMon B202 (JR Medical Ltd, Tallinn, Estonia) is used for the measurement of whole-body impedance cardiography derived heart rate, cardiac index, left cardiac work index, systemic vascular resistance index (SVRI), and extracellular water (ECW). Surgical procedure, anaesthesia and cardio protection will be carried out as in standard care. Echo cardiography will be done pre- and postoperatively. Haemodynamics will be recorded hourly and mixed venous saturation every fourth hour for 24 hours.


Condition or disease Intervention/treatment Phase
Heart Valve Disease Drug: levosimendan Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting
Study Start Date : January 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: levosimendan Drug: levosimendan
12 mcg/kg/10min bolus and 24 hour infusion at a rate of 0.2 mcg/kg/min

Placebo Comparator: placebo Drug: placebo
nacl 0.9% coloured with thiamin in same volume and time than levosimendan




Primary Outcome Measures :
  1. blood pressure [ Time Frame: up to 5 days ]

Secondary Outcome Measures :
  1. echocardiography [ Time Frame: baseline, 1st and 5th postoperative day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LVEF less than 50% of left ventricular hypertrophy indicated by wall thickness more than 12mm

Exclusion Criteria:

  • allergy to levosimendan

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210976


Locations
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Finland
Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
Tampere University Hospital
Investigators
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Principal Investigator: Heli Leppikangas, MD Department of Anaesthesia, Tampere UH
Study Chair: Kati Järvelä, MD,PhD Heart Center, Pirkanmaa Hospital District
Study Chair: Tero Sisto, MD, PhD Heart Center, Pirkanmaa Hospital District
Study Chair: Pasi Maaranen, MD Heart Center, Pirkanmaa Hospitla District
Study Chair: Pasi Lehto, MD,PhD Heart Center, Pirkanmaa Hospital District
Study Chair: Marko Virtanen, MD,PhD Heart Center, Pirkanmaa Hospital District
Study Chair: Sari Karlsson, MD Department of Intensive Care, Tampere UH
Study Chair: Esko Ruokonen, MD,PhD Department of Intensive Care, Kuopio UH
Study Director: Leena Lindgren, MD,PhD Department of Anaesthesia, Tampere UH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01210976    
Other Study ID Numbers: R08039M
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: September 21, 2011
Last Verified: September 2011
Keywords provided by Tampere University Hospital:
levosimendan
CABG
AVR
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Simendan
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs