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

Heart Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210976
• Other study ID #: R08039M
• Status: Completed
• Phase: Phase 4
• First received: September 24, 2010
• Last updated: September 20, 2011
• Start date: January 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2011
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• allergy to levosimendan

Study Design

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

Related Conditions & MeSH terms

• Heart Valve Disease
• Heart Valve Diseases

Intervention

Drug:
• levosimendan
12 mcg/kg/10min bolus and 24 hour infusion at a rate of 0.2 mcg/kg/min
• placebo
nacl 0.9% coloured with thiamin in same volume and time than levosimendan

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure		up to 5 days	Yes
Secondary	echocardiography		baseline, 1st and 5th postoperative day	No