Back to resultsEffects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
Primary Purpose
Diastolic Dysfunction, Left Ventricular Hypertrophy
Status
Terminated
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
levosimendan
placebo drug
Sponsored by
About this trial
This is an interventional treatment trial for Diastolic Dysfunction focused on measuring levosimendan, heart failure, inotropics, diastolic dysfunction, left ventricular hypertrophy, aortic valve stenosis
Eligibility Criteria
Inclusion Criteria:
- Eligible for aortic valve replacement
- EF > 45%
- Left ventricular posterior wall > 12mm
- Sinus rhythm
Exclusion Criteria:
- Concomitant bypass operation
- Severe mitral insufficiency
- Active endocarditis
- Insufficient ultrasound opportunity
- Systolic blood pressure < 100 mmHg
- moderate-severe renal failure
- allergy to levosimendan
- lack of patient consent Pregnancy or status of lactating
- Fertile women who do not use relevant anticonception
Sites / Locations
- Department of Anaesthesiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
levosimendan
Placebo
Arm Description
infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation
Identical placebo
Outcomes
Primary Outcome Measures
E/E'(Unitless)
Ration between early transmitral flow (E) and mitral annular tissue velocity(E'). This ratio is an echocardiographic index of diastolic function
Secondary Outcome Measures
Isovolumetric Relaxation Time (IVRT) (s)
Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function
Ejection Fraction (Per Cent)
Transeosophageal echocardiography: Measure of systolic function
Cardiac Index (l/Min/m2)
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Central Venous Pressure (mmHg)
Invasive measurement of pressure in the vena cava
Pulmonary Artery Pressures (mmHg)
Invasive measurement of mean pressure in the pulmonary artery
Systemic Arterial Pressure (mmHg)
Invasive measurements of arterial mean pressure
N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)
blood sample reflecting stretch of the atrium/ventricle
Troponin T (ug/l)
Blood sample expressing damage to the myocytes
Lactate (mmol/l)
Arterial sampling of blood lactate
Mixed Venous Oxygenation (Per Cent)
Oxygen content (per cent of hemoglobin saturated) of venous blood in pulmonary artery
E/A Ratio (Unitless)
TEE ratio between early (E) transmitral flow and late (A) transmitral flow. An index of diastolic function althought not validated properly yet when measured from the oesophagus
Regional Longitudinal Strain (Unitless)
Transoesophageal echocardiographic (TEE) measure of systolic function. At this time not validated properly against acknowledged indices of systolic function.
Need for Conventional Inotropical Agents
Conventional inotropics are comprised of all inotropics acting primarily through alfa- or beta- stimulation.
Intravenous Fluid Requirement (l)
Total volume of intravenous fluid required including blood products.
Operation Time (Minutes)
Time on Heart-lung Machine (Minutes)
Intubation Time (Minutes)
Total time intubated including time of operation and in the intensive care ward
Postoperative Admission Time at Intensive Care Unit (Hours)
Total admission time in the intensive care after operation
No. of Patients With Adverse Events
Development of Ventricular tachycardia
No. of Patients With Adverse Event
Development of atrial flutter/fibrillation
No. of Patients With Adverse Event
Need for norepinephrine as an antagonist to the vasodilatatory effect of levosimendan
No. of Patients With Adverse Event.
Occurence of nausea
No. of Patients With Adverse Event
Occurence of headache
Regional Longitudinal Strain (Unitless)
Index of systolic function derived from single transthoracic echocardiographic (TTE) projection
Ejection Fraction (Per Cent)
TTE: Index of systolic function
Ejection Fraction (Per Cent)
TTE: Index of systolic function
Ejection Fraction (Per Cent)
TTE: Index of systolic function
Regional Longitudinal Strain (Unitless)
Transoesophageal echocardiographic (TEE) measure of systolic function. At this time not validated properly against acknowledged indices of systolic function.
E/A Ratio (Unitless)
TEE ratio between early (E) transmitral flow and late (A) transmitral flow. An index of diastolic function althought not validated properly yet when measured from the oesophagus
Left Ventricular Rotation (Degrees)
TTE: Index of both systolic and diastolic function
Mixed Venous Oxygenation (Per Cent)
Oxygen content (per cent of hemoglobin saturated) of venous blood in pulmonary artery
Lactate (mmol/l)
Arterial sampling of blood lactate
Troponin T (ug/l)
Blood sample expressing damage to the myocytes
Troponin T (ug/l)
Blood sample expressing damage to the myocytes
N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)
blood sample reflecting stretch of the atrium/ventricle
N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)
blood sample reflecting stretch of the atrium/ventricle
Systemic Arterial Pressure (mmHg)
Invasive measurements of arterial mean pressure
Systemic Arterial Pressure (mmHg)
Invasive measurements of arterial mean pressure
Systemic Arterial Pressure (mmHg)
Invasive measurements of arterial mean pressure
Systemic Arterial Pressure (mmHg)
Invasive measurements of arterial mean pressure
Pulmonary Artery Pressures (mmHg)
Invasive measurement of mean pressure in the pulmonary artery
Pulmonary Artery Pressures (mmHg)
Invasive measurement of mean pressure in the pulmonary artery
Pulmonary Artery Pressures (mmHg)
Invasive measurement of mean pressure in the pulmonary artery
Pulmonary Artery Pressures (mmHg)
Invasive measurement of mean pressure in the pulmonary artery
Regional Longitudinal Strain (Unitless)
Index of systolic function derived from single transthoracic echocardiographic (TTE) projection
Regional Longitudinal Strain (Unitless)
Index of systolic function derived from single transthoracic echocardiographic (TTE) projection
Regional Longitudinal Strain (Unitless)
Index of systolic function derived from single transthoracic echocardiographic (TTE) projection
Central Venous Pressure (mmHg)
Invasive measurement of pressure in the vena cava
Central Venous Pressure (mmHg)
Invasive measurement of pressure in the vena cava
Central Venous Pressure (mmHg)
Invasive measurement of pressure in the vena cava
Central Venous Pressure (mmHg)
Invasive measurement of pressure in the vena cava
Peak Systolic Velocity (m/s)
Tissue Doppler measure of systolic function
Peak Systolic Velocity (m/s)
Tissue Doppler measure of systolic function
Peak Systolic Velocity (m/s)
Tissue Doppler measure of systolic function
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
Transthoracic echocardiographic measure of systolic function
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
Transthoracic echocardiographic measure of systolic function
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
Transthoracic echocardiographic measure of systolic function
E/A-ratio (Unitless)
Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.
E/A-ratio (Unitless)
Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.
E/A-ratio (Unitless)
Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.
E'/A'-Ratio (Unitless)
Tissue Doppler transthoracic echocardiography: Ratio between tissue velocities at the mitral plan during early (E) diastole and late (A) diastole. Index of diastolic function.
E'/A'-Ratio (Unitless)
Tissue Doppler transthoracic echocardiography: Ratio between tissue velocities at the mitral plan during early (E) diastole and late (A) diastole. Index of diastolic function.
E'/A'-Ratio (Unitless)
Tissue Doppler transthoracic echocardiography: Ratio between tissue velocities at the mitral plan during early (E) diastole and late (A) diastole. Index of diastolic function.
Isovolumetric Relaxation Time (IVRT) (s)
Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function
Isovolumetric Relaxation Time (IVRT) (s)
Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function
Isovolumetric Relaxation Time (IVRT) (s)
Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function
Ejection Fraction (Per Cent)
Transeosophageal echocardiography: Measure of systolic function
Isovolumetric Relaxation Time (IVRT) (s)
Transeosophageal echocardiography: Time from closure of aortic valve to opening of mitral valve. Measure of diastolic function.
Cardiac Index (l/Min/m2)
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Cardiac Index (l/Min/m2)
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Cardiac Index (l/Min/m2)
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Cardiac Index (l/Min/m2)
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Inflammatory Parameters
Blood sample values of pro- and antiinflammatory mediators
Inflammatory Parameters
Blood sample values of pro- and antiinflammatory mediators
E/A-ratio (Transoesophageal)
Transoesophageal echocardiographic measure of diastolic heart function
E/A-ratio (Transoesophageal)
Transoesophageal echocardiographic measure of diastolic heart function
Urine Clearance
Urine analysis. Measure of kidney function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01188369
Brief Title
Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
Official Title
Effects of Levosimendan on Systolic Deformation and Diastolic Function in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Terminated prematurely due to high incidence of postoperative atrial fibrillation.
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of surgery.
Detailed Description
Levosimendan or placebo will be infusion for approximately 4 hours prior to aortic valve replacement in patients with severe hypertrophy of the left ventricle and echocardiographic signs of diastolic dysfunction. Outcome measures will be obtained at some of the following:
Approximately 4 hours prior to surgery. Baseline. Start of levosimendan/placebo infusion
Immediately before surgery
After induction of anaesthesia and before "knife time" = start of surgery.
At the end of surgery: Levosimendan infusion will stop.
Approximately 4 hours after surgery immediately before extubation.
Approximately 21 hours after surgery
Approximately 96 hours after surgery (day 4)
6 months after surgery
Outcome measures are comprised of invasive measurements, blood samples, transthoracic echocardiography and transoesophageal echocardiography focusing on measures of systolic and diastolic function of the heart.
Interim analysis will be conducted after 30 included patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Dysfunction, Left Ventricular Hypertrophy
Keywords
levosimendan, heart failure, inotropics, diastolic dysfunction, left ventricular hypertrophy, aortic valve stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
levosimendan
Arm Type
Experimental
Arm Description
infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical placebo
Intervention Type
Drug
Intervention Name(s)
levosimendan
Other Intervention Name(s)
Simdax
Intervention Description
Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation.
Intervention Type
Drug
Intervention Name(s)
placebo drug
Other Intervention Name(s)
Placebo
Intervention Description
Intravenous infusion, colour identical to levosimendan
Primary Outcome Measure Information:
Title
E/E'(Unitless)
Description
Ration between early transmitral flow (E) and mitral annular tissue velocity(E'). This ratio is an echocardiographic index of diastolic function
Time Frame
4 hours before operation until 21 hour after operation
Secondary Outcome Measure Information:
Title
Isovolumetric Relaxation Time (IVRT) (s)
Description
Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function
Time Frame
4 hours before surgery until 1 hour before operation
Title
Ejection Fraction (Per Cent)
Description
Transeosophageal echocardiography: Measure of systolic function
Time Frame
At start of operation until end of operation, approximately 3 hours
Title
Cardiac Index (l/Min/m2)
Description
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Time Frame
4 hours before operation until 1 hour before operation
Title
Central Venous Pressure (mmHg)
Description
Invasive measurement of pressure in the vena cava
Time Frame
4 hours before operation until 1 hours before operation
Title
Pulmonary Artery Pressures (mmHg)
Description
Invasive measurement of mean pressure in the pulmonary artery
Time Frame
4 hours before operation until 1 hour before operation
Title
Systemic Arterial Pressure (mmHg)
Description
Invasive measurements of arterial mean pressure
Time Frame
4 hours before operation until 1 hour before operation
Title
N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)
Description
blood sample reflecting stretch of the atrium/ventricle
Time Frame
4 hours before operation until 4 hours after operation
Title
Troponin T (ug/l)
Description
Blood sample expressing damage to the myocytes
Time Frame
4 hours before operation until 4 hours after operation
Title
Lactate (mmol/l)
Description
Arterial sampling of blood lactate
Time Frame
4 hours before operation until 4 hour after operation
Title
Mixed Venous Oxygenation (Per Cent)
Description
Oxygen content (per cent of hemoglobin saturated) of venous blood in pulmonary artery
Time Frame
4 hours before operation until 4 hour after operation
Title
E/A Ratio (Unitless)
Description
TEE ratio between early (E) transmitral flow and late (A) transmitral flow. An index of diastolic function althought not validated properly yet when measured from the oesophagus
Time Frame
At the start of operation until the end of operationon, approximately 3 hours
Title
Regional Longitudinal Strain (Unitless)
Description
Transoesophageal echocardiographic (TEE) measure of systolic function. At this time not validated properly against acknowledged indices of systolic function.
Time Frame
At the start of operation until the end of operation, approximately 3 hours
Title
Need for Conventional Inotropical Agents
Description
Conventional inotropics are comprised of all inotropics acting primarily through alfa- or beta- stimulation.
Time Frame
From start of operation until 5 days after operation
Title
Intravenous Fluid Requirement (l)
Description
Total volume of intravenous fluid required including blood products.
Time Frame
Within 24 hours from start of operation
Title
Operation Time (Minutes)
Time Frame
From "knife start" until "knife end", approximately 3 hours
Title
Time on Heart-lung Machine (Minutes)
Time Frame
From time of cardioplegia until selfsufficient cardiac action, approximately 1 hour
Title
Intubation Time (Minutes)
Description
Total time intubated including time of operation and in the intensive care ward
Time Frame
From intubation until extubation, approximately 6 hours
Title
Postoperative Admission Time at Intensive Care Unit (Hours)
Description
Total admission time in the intensive care after operation
Time Frame
From admission to the intensive care unit until discharge from intensive care unit, approximately 24 hours
Title
No. of Patients With Adverse Events
Description
Development of Ventricular tachycardia
Time Frame
-4 hours until + 96 hours with respect to start of operation
Title
No. of Patients With Adverse Event
Description
Development of atrial flutter/fibrillation
Time Frame
-4 hours until + 96 hours with respect to start of operation
Title
No. of Patients With Adverse Event
Description
Need for norepinephrine as an antagonist to the vasodilatatory effect of levosimendan
Time Frame
4 hours before operaton until 1 hour before operaton
Title
No. of Patients With Adverse Event.
Description
Occurence of nausea
Time Frame
4 hours before operation until 1 hour before operation
Title
No. of Patients With Adverse Event
Description
Occurence of headache
Time Frame
4 hours before operation until approximately 1 hour before operation
Title
Regional Longitudinal Strain (Unitless)
Description
Index of systolic function derived from single transthoracic echocardiographic (TTE) projection
Time Frame
4 hours before until 1 hour before start of operation
Title
Ejection Fraction (Per Cent)
Description
TTE: Index of systolic function
Time Frame
1 hour before until 21 hour after start of operation
Title
Ejection Fraction (Per Cent)
Description
TTE: Index of systolic function
Time Frame
21 hours after operation until 96 hours after start of operation
Title
Ejection Fraction (Per Cent)
Description
TTE: Index of systolic function
Time Frame
96 hours after operation until 6 months after operation
Title
Regional Longitudinal Strain (Unitless)
Description
Transoesophageal echocardiographic (TEE) measure of systolic function. At this time not validated properly against acknowledged indices of systolic function.
Time Frame
Froml the end of operation until approx 4 hours after operation
Title
E/A Ratio (Unitless)
Description
TEE ratio between early (E) transmitral flow and late (A) transmitral flow. An index of diastolic function althought not validated properly yet when measured from the oesophagus
Time Frame
At the end of operationon until approx 4 hours after operation
Title
Left Ventricular Rotation (Degrees)
Description
TTE: Index of both systolic and diastolic function
Time Frame
96 hour after operation until 6 months after operation
Title
Mixed Venous Oxygenation (Per Cent)
Description
Oxygen content (per cent of hemoglobin saturated) of venous blood in pulmonary artery
Time Frame
4 hours after operation until 21 hours after operation
Title
Lactate (mmol/l)
Description
Arterial sampling of blood lactate
Time Frame
4 hours after operation until 21 hours after operation
Title
Troponin T (ug/l)
Description
Blood sample expressing damage to the myocytes
Time Frame
4 hours after operation until 21 hours after operation
Title
Troponin T (ug/l)
Description
Blood sample expressing damage to the myocytes
Time Frame
21 hours after operation until 96 hours after operation
Title
N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)
Description
blood sample reflecting stretch of the atrium/ventricle
Time Frame
4 hours after operation until 21 hours after operation
Title
N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)
Description
blood sample reflecting stretch of the atrium/ventricle
Time Frame
21 hours after operation until 96 hours after operation
Title
Systemic Arterial Pressure (mmHg)
Description
Invasive measurements of arterial mean pressure
Time Frame
1 hour before operation until start of operation
Title
Systemic Arterial Pressure (mmHg)
Description
Invasive measurements of arterial mean pressure
Time Frame
Start of operation until the end of operation, approximately 3 hours
Title
Systemic Arterial Pressure (mmHg)
Description
Invasive measurements of arterial mean pressure
Time Frame
End of operation until approx 4 hours after operation
Title
Systemic Arterial Pressure (mmHg)
Description
Invasive measurements of arterial mean pressure
Time Frame
4 hours after operation until 21 hours after operation
Title
Pulmonary Artery Pressures (mmHg)
Description
Invasive measurement of mean pressure in the pulmonary artery
Time Frame
1 hour before operation until start of operation
Title
Pulmonary Artery Pressures (mmHg)
Description
Invasive measurement of mean pressure in the pulmonary artery
Time Frame
Start of operation until end of operation, approximately 3 hours
Title
Pulmonary Artery Pressures (mmHg)
Description
Invasive measurement of mean pressure in the pulmonary artery
Time Frame
End of operation until approx 4 hours after operation
Title
Pulmonary Artery Pressures (mmHg)
Description
Invasive measurement of mean pressure in the pulmonary artery
Time Frame
4 hours after operation until 21 hours after operation
Title
Regional Longitudinal Strain (Unitless)
Description
Index of systolic function derived from single transthoracic echocardiographic (TTE) projection
Time Frame
1 hour before start of operation until 21 hours after operation
Title
Regional Longitudinal Strain (Unitless)
Description
Index of systolic function derived from single transthoracic echocardiographic (TTE) projection
Time Frame
21 hours after operation until 96 hours after operation
Title
Regional Longitudinal Strain (Unitless)
Description
Index of systolic function derived from single transthoracic echocardiographic (TTE) projection
Time Frame
96 hours after operation until 6 months after operation
Title
Central Venous Pressure (mmHg)
Description
Invasive measurement of pressure in the vena cava
Time Frame
1 hour before operation until start of operation
Title
Central Venous Pressure (mmHg)
Description
Invasive measurement of pressure in the vena cava
Time Frame
Start of operation until end of operation, approximately 3 hours
Title
Central Venous Pressure (mmHg)
Description
Invasive measurement of pressure in the vena cava
Time Frame
End of operation until approx 4 hours after operation
Title
Central Venous Pressure (mmHg)
Description
Invasive measurement of pressure in the vena cava
Time Frame
4 hours after operation until 21 hours after operation
Title
Peak Systolic Velocity (m/s)
Description
Tissue Doppler measure of systolic function
Time Frame
1 hour before operation until 21 hours after operation
Title
Peak Systolic Velocity (m/s)
Description
Tissue Doppler measure of systolic function
Time Frame
21 hours after operation until 96 hours after operation
Title
Peak Systolic Velocity (m/s)
Description
Tissue Doppler measure of systolic function
Time Frame
96 hours after operation until 6 months after operation
Title
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
Description
Transthoracic echocardiographic measure of systolic function
Time Frame
1 hour before operation until 21 hours after operation
Title
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
Description
Transthoracic echocardiographic measure of systolic function
Time Frame
21 hours after operation until 96 hours after operation
Title
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
Description
Transthoracic echocardiographic measure of systolic function
Time Frame
96 hours after operation until 6 months after operation
Title
E/A-ratio (Unitless)
Description
Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.
Time Frame
1 hour before operation until 21 hours after operation
Title
E/A-ratio (Unitless)
Description
Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.
Time Frame
21 hours after operation until 96 hours after operation
Title
E/A-ratio (Unitless)
Description
Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.
Time Frame
96 hours after operation until 6 months after operation
Title
E'/A'-Ratio (Unitless)
Description
Tissue Doppler transthoracic echocardiography: Ratio between tissue velocities at the mitral plan during early (E) diastole and late (A) diastole. Index of diastolic function.
Time Frame
1 hour before operation until 21 hours after roperation
Title
E'/A'-Ratio (Unitless)
Description
Tissue Doppler transthoracic echocardiography: Ratio between tissue velocities at the mitral plan during early (E) diastole and late (A) diastole. Index of diastolic function.
Time Frame
21 hours after operation until 96 hours after operation
Title
E'/A'-Ratio (Unitless)
Description
Tissue Doppler transthoracic echocardiography: Ratio between tissue velocities at the mitral plan during early (E) diastole and late (A) diastole. Index of diastolic function.
Time Frame
96 hours after operation until 6 months after operation
Title
Isovolumetric Relaxation Time (IVRT) (s)
Description
Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function
Time Frame
1 hour before operation until 21 hours after operation
Title
Isovolumetric Relaxation Time (IVRT) (s)
Description
Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function
Time Frame
21 hours after operation until 96 hours after operation
Title
Isovolumetric Relaxation Time (IVRT) (s)
Description
Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function
Time Frame
96 hours after operation until 6 months after operation
Title
Ejection Fraction (Per Cent)
Description
Transeosophageal echocardiography: Measure of systolic function
Time Frame
End of operation until approx. 4 hours after operation
Title
Isovolumetric Relaxation Time (IVRT) (s)
Description
Transeosophageal echocardiography: Time from closure of aortic valve to opening of mitral valve. Measure of diastolic function.
Time Frame
End of operation until approx. 4 hours after operation
Title
Cardiac Index (l/Min/m2)
Description
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Time Frame
1 hour before operation until start of operation
Title
Cardiac Index (l/Min/m2)
Description
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Time Frame
Start of operation until end of operation, approximately 3 hours
Title
Cardiac Index (l/Min/m2)
Description
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Time Frame
End of operation operation until approx. 4 hours after operation
Title
Cardiac Index (l/Min/m2)
Description
Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)
Time Frame
4 hours after operation until 21 hours after operation
Title
Inflammatory Parameters
Description
Blood sample values of pro- and antiinflammatory mediators
Time Frame
4 hours before operation until 21 hours after operation
Title
Inflammatory Parameters
Description
Blood sample values of pro- and antiinflammatory mediators
Time Frame
21 hours after operation until 96 hours after operation
Title
E/A-ratio (Transoesophageal)
Description
Transoesophageal echocardiographic measure of diastolic heart function
Time Frame
from start of operation until end of operation, approximately 3 hours
Title
E/A-ratio (Transoesophageal)
Description
Transoesophageal echocardiographic measure of diastolic heart function
Time Frame
from end of operation until approximately 4 hours after operation
Title
Urine Clearance
Description
Urine analysis. Measure of kidney function.
Time Frame
from start of operation until 24 hours after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible for aortic valve replacement
EF > 45%
Left ventricular posterior wall > 12mm
Sinus rhythm
Exclusion Criteria:
Concomitant bypass operation
Severe mitral insufficiency
Active endocarditis
Insufficient ultrasound opportunity
Systolic blood pressure < 100 mmHg
moderate-severe renal failure
allergy to levosimendan
lack of patient consent Pregnancy or status of lactating
Fertile women who do not use relevant anticonception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Juhl-Olsen, M.D.
Organizational Affiliation
Department of Anaesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anaesthesiology
City
Århus N
State/Province
Region Midtjylland
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
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