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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01188369
Date of registration: 10/08/2010
Primary sponsor: University of Aarhus
Public title: Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
Scientific title: Effects of Levosimendan on Systolic Deformation and Diastolic Function in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
Date of first enrolment: September 2010
Target sample size: 20
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT01188369
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Countries of recruitment
Denmark
Contacts
Name:   Peter Juhl-Olsen, M.D.
Address: 
Telephone:
Email:
Affiliation:  Department of Anaesthesiology
Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 90 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Diastolic Dysfunction
Left Ventricular Hypertrophy
Intervention(s)
Drug: levosimendan
Drug: placebo drug
Primary Outcome(s)
E/E'(unitless) [Time Frame: 4 hours before operation until 21 hour after operation]
Secondary Outcome(s)
Cardiac index (l/min/m2) [Time Frame: 1 hour before operation until start of operation]
Cardiac index (l/min/m2) [Time Frame: 4 hours after operation until 21 hours after operation]
Cardiac index (l/min/m2) [Time Frame: 4 hours before operation until 1 hour before operation]
Cardiac index (l/min/m2) [Time Frame: End of operation operation until approx. 4 hours after operation]
Cardiac index (l/min/m2) [Time Frame: Start of operation until end of operation, approximately 3 hours]
Central venous pressure (mmHg) [Time Frame: 1 hour before operation until start of operation]
Central venous pressure (mmHg) [Time Frame: 4 hours after operation until 21 hours after operation]
Central venous pressure (mmHg) [Time Frame: 4 hours before operation until 1 hours before operation]
Central venous pressure (mmHg) [Time Frame: End of operation until approx 4 hours after operation]
Central venous pressure (mmHg) [Time Frame: Start of operation until end of operation, approximately 3 hours]
E'/A'-ratio (unitless) [Time Frame: 1 hour before operation until 21 hours after roperation]
E'/A'-ratio (unitless) [Time Frame: 21 hours after operation until 96 hours after operation]
E'/A'-ratio (unitless) [Time Frame: 4 hours before operation until 1 hour before operation]
E'/A'-ratio (unitless) [Time Frame: 96 hours after operation until 6 months after operation]
E/A ratio (unitless) [Time Frame: At the end of operationon until approx 4 hours after operation]
E/A ratio (unitless) [Time Frame: At the start of operation until the end of operationon, approximately 3 hours]
E/A-ratio (transoesophageal) [Time Frame: from end of operation until approximately 4 hours after operation]
E/A-ratio (transoesophageal) [Time Frame: from start of operation until end of operation, approximately 3 hours]
E/A-ratio (unitless) [Time Frame: 1 hour before operation until 21 hours after operation]
E/A-ratio (unitless) [Time Frame: 21 hours after operation until 96 hours after operation]
E/A-ratio (unitless) [Time Frame: 4 hours before operation until 1 hour before operation]
E/A-ratio (unitless) [Time Frame: 96 hours after operation until 6 months after operation]
E/E' (unitless) [Time Frame: 21 hours after operation until 96 hours after operation]
Ejection fraction (per cent) [Time Frame: 1 hour before until 21 hour after start of operation]
Ejection fraction (per cent) [Time Frame: 21 hours after operation until 96 hours after start of operation]
Ejection fraction (per cent) [Time Frame: 4 hours before until 1 hour before start of operation]
Ejection fraction (per cent) [Time Frame: 96 hours after operation until 6 months after operation]
Ejection fraction (per cent) [Time Frame: At start of operation until end of operation, approximately 3 hours]
Ejection fraction (per cent) [Time Frame: End of operation until approx. 4 hours after operation]
Inflammatory parameters [Time Frame: 21 hours after operation until 96 hours after operation]
Inflammatory parameters [Time Frame: 4 hours before operation until 21 hours after operation]
Intravenous fluid requirement (l) [Time Frame: Within 24 hours from start of operation]
Intubation time (minutes) [Time Frame: From intubation until extubation, approximately 6 hours]
Isovolumetric relaxation time (IVRT) (s) [Time Frame: 1 hour before operation until 21 hours after operation]
Isovolumetric relaxation time (IVRT) (s) [Time Frame: 21 hours after operation until 96 hours after operation]
Isovolumetric relaxation time (IVRT) (s) [Time Frame: 4 hours before surgery until 1 hour before operation]
Isovolumetric relaxation time (IVRT) (s) [Time Frame: 96 hours after operation until 6 months after operation]
Isovolumetric relaxation time (IVRT) (s) [Time Frame: End of operation until approx. 4 hours after operation]
lactate (mmol/l) [Time Frame: 4 hours after operation until 21 hours after operation]
lactate (mmol/l) [Time Frame: 4 hours before operation until 4 hour after operation]
Left ventricular rotation (degrees) [Time Frame: 96 hour after operation until 6 months after operation]
Mixed venous oxygenation (per cent) [Time Frame: 4 hours after operation until 21 hours after operation]
Mixed venous oxygenation (per cent) [Time Frame: 4 hours before operation until 4 hour after operation]
N-terminal pro Brain natriuretic peptide (NT proBNP)(pg/ml) [Time Frame: 21 hours after operation until 96 hours after operation]
N-terminal pro Brain natriuretic peptide (NT proBNP)(pg/ml) [Time Frame: 4 hours after operation until 21 hours after operation]
N-terminal pro Brain natriuretic peptide (NT proBNP)(pg/ml) [Time Frame: 4 hours before operation until 4 hours after operation]
Need for conventional inotropical agents [Time Frame: From start of operation until 5 days after operation]
No. of patients with adverse event [Time Frame: -4 hours until + 96 hours with respect to start of operation]
No. of patients with adverse event [Time Frame: 4 hours before operation until approximately 1 hour before operation]
No. of patients with adverse event [Time Frame: 4 hours before operaton until 1 hour before operaton]
No. of patients with adverse event. [Time Frame: 4 hours before operation until 1 hour before operation]
No. of patients with adverse events [Time Frame: -4 hours until + 96 hours with respect to start of operation]
Operation time (minutes) [Time Frame: From "knife start" until "knife end", approximately 3 hours]
Peak systolic velocity (m/s) [Time Frame: 1 hour before operation until 21 hours after operation]
Peak systolic velocity (m/s) [Time Frame: 21 hours after operation until 96 hours after operation]
Peak systolic velocity (m/s) [Time Frame: 4 hours before operation until 1 hour before operation]
Peak systolic velocity (m/s) [Time Frame: 96 hours after operation until 6 months after operation]
Postoperative admission time at intensive care unit (hours) [Time Frame: From admission to the intensive care unit until discharge from intensive care unit, approximately 24 hours]
Pulmonary artery pressures (mmHg) [Time Frame: 1 hour before operation until start of operation]
Pulmonary artery pressures (mmHg) [Time Frame: 4 hours after operation until 21 hours after operation]
Pulmonary artery pressures (mmHg) [Time Frame: 4 hours before operation until 1 hour before operation]
Pulmonary artery pressures (mmHg) [Time Frame: End of operation until approx 4 hours after operation]
Pulmonary artery pressures (mmHg) [Time Frame: Start of operation until end of operation, approximately 3 hours]
Regional longitudinal strain (unitless) [Time Frame: 1 hour before start of operation until 21 hours after operation]
Regional longitudinal strain (unitless) [Time Frame: 21 hours after operation until 96 hours after operation]
Regional longitudinal strain (unitless) [Time Frame: 4 hours before until 1 hour before start of operation]
Regional longitudinal strain (unitless) [Time Frame: 96 hours after operation until 6 months after operation]
Regional longitudinal strain (unitless) [Time Frame: At the start of operation until the end of operation, approximately 3 hours]
Regional longitudinal strain (unitless) [Time Frame: Froml the end of operation until approx 4 hours after operation]
Systemic arterial pressure (mmHg) [Time Frame: 1 hour before operation until start of operation]
Systemic arterial pressure (mmHg) [Time Frame: 4 hours after operation until 21 hours after operation]
Systemic arterial pressure (mmHg) [Time Frame: 4 hours before operation until 1 hour before operation]
Systemic arterial pressure (mmHg) [Time Frame: End of operation until approx 4 hours after operation]
Systemic arterial pressure (mmHg) [Time Frame: Start of operation until the end of operation, approximately 3 hours]
Time on heart-lung machine (minutes) [Time Frame: From time of cardioplegia until selfsufficient cardiac action, approximately 1 hour]
Tricuspid annular plane systolic excursion (TAPSE) (mm) [Time Frame: 1 hour before operation until 21 hours after operation]
Tricuspid annular plane systolic excursion (TAPSE) (mm) [Time Frame: 21 hours after operation until 96 hours after operation]
Tricuspid annular plane systolic excursion (TAPSE) (mm) [Time Frame: 4 hours before operation until 1 hour before operation]
Tricuspid annular plane systolic excursion (TAPSE) (mm) [Time Frame: 96 hours after operation until 6 months after operation]
Troponin T (ug/l) [Time Frame: 21 hours after operation until 96 hours after operation]
Troponin T (ug/l) [Time Frame: 4 hours after operation until 21 hours after operation]
Troponin T (ug/l) [Time Frame: 4 hours before operation until 4 hours after operation]
urine clearance [Time Frame: from start of operation until 24 hours after operation]
Secondary ID(s)
1616
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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