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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01210976

Enrollment

Registered

2010-09-29

Start date

2009-01-31

Completion date

2010-09-30

Last updated

2011-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Disease

Keywords

levosimendan, CABG, AVR

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.

Interventions

DRUGlevosimendan

12 mcg/kg/10min bolus and 24 hour infusion at a rate of 0.2 mcg/kg/min

DRUGplacebo

nacl 0.9% coloured with thiamin in same volume and time than levosimendan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* allergy to levosimendan

Design outcomes

Primary

Measure	Time frame
blood pressure	up to 5 days

Secondary

Measure	Time frame
echocardiography	baseline, 1st and 5th postoperative day

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026