Back to results

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

Primary Purpose

Heart Valve Disease

Status

Completed

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

levosimendan

placebo

About this trial

This is an interventional treatment trial for Heart Valve Disease focused on measuring levosimendan, CABG, AVR

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

allergy to levosimendan

Sites / Locations

Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

levosimendan

placebo

Arm Description

Outcomes

Primary Outcome Measures

blood pressure

Secondary Outcome Measures

echocardiography

Full Information

NCT ID

NCT01210976

First Posted

September 24, 2010

Last Updated

September 20, 2011

Sponsor

Tampere University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01210976

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tampere University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Valve Disease

Keywords

levosimendan, CABG, AVR

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

levosimendan

Arm Type

Experimental

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

levosimendan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

blood pressure

Time Frame

up to 5 days

Secondary Outcome Measure Information:

Title

echocardiography

Time Frame

baseline, 1st and 5th postoperative day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: LVEF less than 50% of left ventricular hypertrophy indicated by wall thickness more than 12mm Exclusion Criteria: allergy to levosimendan

Overall Study Officials: