Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-30 @ 6:16 AM
Study NCT ID:
NCT01188369
Status:
TERMINATED
Last Update Posted:
2018-12-03
First Post:
2010-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077464', 'term': 'Simendan'}], 'ancestors': [{'id': 'D006835', 'term': 'Hydrazones'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011724', 'term': 'Pyridazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peter.juhl-olsen@ki.au.dk', 'phone': '+4578451199', 'title': 'Dr. Peter Juhl-Olsen', 'organization': 'Aarhus University Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Levosimendan', 'description': 'infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation\n\nlevosimendan: Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation.', 'otherNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Identical placebo\n\nplacebo drug: Intravenous infusion, colour identical to levosimendan', 'otherNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Postoperative atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "E/E'(Unitless)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levosimendan', 'description': 'infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation\n\nlevosimendan: Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical placebo\n\nplacebo drug: Intravenous infusion, colour identical to levosimendan'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '24.6'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '28.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 hours before operation until 21 hour after operation', 'description': "Ration between early transmitral flow (E) and mitral annular tissue velocity(E'). This ratio is an echocardiographic index of diastolic function", 'unitOfMeasure': 'Unitless', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Isovolumetric Relaxation Time (IVRT) (s)', 'timeFrame': '4 hours before surgery until 1 hour before operation', 'description': 'Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Ejection Fraction (Per Cent)', 'timeFrame': 'At start of operation until end of operation, approximately 3 hours', 'description': 'Transeosophageal echocardiography: Measure of systolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Cardiac Index (l/Min/m2)', 'timeFrame': '4 hours before operation until 1 hour before operation', 'description': 'Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Central Venous Pressure (mmHg)', 'timeFrame': '4 hours before operation until 1 hours before operation', 'description': 'Invasive measurement of pressure in the vena cava', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Pulmonary Artery Pressures (mmHg)', 'timeFrame': '4 hours before operation until 1 hour before operation', 'description': 'Invasive measurement of mean pressure in the pulmonary artery', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Systemic Arterial Pressure (mmHg)', 'timeFrame': '4 hours before operation until 1 hour before operation', 'description': 'Invasive measurements of arterial mean pressure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)', 'timeFrame': '4 hours before operation until 4 hours after operation', 'description': 'blood sample reflecting stretch of the atrium/ventricle', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Troponin T (ug/l)', 'timeFrame': '4 hours before operation until 4 hours after operation', 'description': 'Blood sample expressing damage to the myocytes', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Lactate (mmol/l)', 'timeFrame': '4 hours before operation until 4 hour after operation', 'description': 'Arterial sampling of blood lactate', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Mixed Venous Oxygenation (Per Cent)', 'timeFrame': '4 hours before operation until 4 hour after operation', 'description': 'Oxygen content (per cent of hemoglobin saturated) of venous blood in pulmonary artery', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'E/A Ratio (Unitless)', 'timeFrame': 'At the start of operation until the end of operationon, approximately 3 hours', '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', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Regional Longitudinal Strain (Unitless)', 'timeFrame': 'At the start of operation until the end of operation, approximately 3 hours', 'description': 'Transoesophageal echocardiographic (TEE) measure of systolic function. At this time not validated properly against acknowledged indices of systolic function.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Need for Conventional Inotropical Agents', 'timeFrame': 'From start of operation until 5 days after operation', 'description': 'Conventional inotropics are comprised of all inotropics acting primarily through alfa- or beta- stimulation.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Intravenous Fluid Requirement (l)', 'timeFrame': 'Within 24 hours from start of operation', 'description': 'Total volume of intravenous fluid required including blood products.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Operation Time (Minutes)', 'timeFrame': 'From "knife start" until "knife end", approximately 3 hours', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Time on Heart-lung Machine (Minutes)', 'timeFrame': 'From time of cardioplegia until selfsufficient cardiac action, approximately 1 hour', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Intubation Time (Minutes)', 'timeFrame': 'From intubation until extubation, approximately 6 hours', 'description': 'Total time intubated including time of operation and in the intensive care ward', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Postoperative Admission Time at Intensive Care Unit (Hours)', 'timeFrame': 'From admission to the intensive care unit until discharge from intensive care unit, approximately 24 hours', 'description': 'Total admission time in the intensive care after operation', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'No. of Patients With Adverse Events', 'timeFrame': '-4 hours until + 96 hours with respect to start of operation', 'description': 'Development of Ventricular tachycardia', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'No. of Patients With Adverse Event', 'timeFrame': '-4 hours until + 96 hours with respect to start of operation', 'description': 'Development of atrial flutter/fibrillation', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'No. of Patients With Adverse Event', 'timeFrame': '4 hours before operaton until 1 hour before operaton', 'description': 'Need for norepinephrine as an antagonist to the vasodilatatory effect of levosimendan', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'No. of Patients With Adverse Event.', 'timeFrame': '4 hours before operation until 1 hour before operation', 'description': 'Occurence of nausea', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'No. of Patients With Adverse Event', 'timeFrame': '4 hours before operation until approximately 1 hour before operation', 'description': 'Occurence of headache', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Regional Longitudinal Strain (Unitless)', 'timeFrame': '4 hours before until 1 hour before start of operation', 'description': 'Index of systolic function derived from single transthoracic echocardiographic (TTE) projection', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Ejection Fraction (Per Cent)', 'timeFrame': '1 hour before until 21 hour after start of operation', 'description': 'TTE: Index of systolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Ejection Fraction (Per Cent)', 'timeFrame': '21 hours after operation until 96 hours after start of operation', 'description': 'TTE: Index of systolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Ejection Fraction (Per Cent)', 'timeFrame': '96 hours after operation until 6 months after operation', 'description': 'TTE: Index of systolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Regional Longitudinal Strain (Unitless)', 'timeFrame': 'Froml the end of operation until approx 4 hours after operation', 'description': 'Transoesophageal echocardiographic (TEE) measure of systolic function. At this time not validated properly against acknowledged indices of systolic function.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'E/A Ratio (Unitless)', 'timeFrame': 'At the end of operationon until approx 4 hours after operation', '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', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Rotation (Degrees)', 'timeFrame': '96 hour after operation until 6 months after operation', 'description': 'TTE: Index of both systolic and diastolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Mixed Venous Oxygenation (Per Cent)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Oxygen content (per cent of hemoglobin saturated) of venous blood in pulmonary artery', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Lactate (mmol/l)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Arterial sampling of blood lactate', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Troponin T (ug/l)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Blood sample expressing damage to the myocytes', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Troponin T (ug/l)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Blood sample expressing damage to the myocytes', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'blood sample reflecting stretch of the atrium/ventricle', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'blood sample reflecting stretch of the atrium/ventricle', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Systemic Arterial Pressure (mmHg)', 'timeFrame': '1 hour before operation until start of operation', 'description': 'Invasive measurements of arterial mean pressure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Systemic Arterial Pressure (mmHg)', 'timeFrame': 'Start of operation until the end of operation, approximately 3 hours', 'description': 'Invasive measurements of arterial mean pressure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Systemic Arterial Pressure (mmHg)', 'timeFrame': 'End of operation until approx 4 hours after operation', 'description': 'Invasive measurements of arterial mean pressure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Systemic Arterial Pressure (mmHg)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Invasive measurements of arterial mean pressure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Pulmonary Artery Pressures (mmHg)', 'timeFrame': '1 hour before operation until start of operation', 'description': 'Invasive measurement of mean pressure in the pulmonary artery', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Pulmonary Artery Pressures (mmHg)', 'timeFrame': 'Start of operation until end of operation, approximately 3 hours', 'description': 'Invasive measurement of mean pressure in the pulmonary artery', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Pulmonary Artery Pressures (mmHg)', 'timeFrame': 'End of operation until approx 4 hours after operation', 'description': 'Invasive measurement of mean pressure in the pulmonary artery', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Pulmonary Artery Pressures (mmHg)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Invasive measurement of mean pressure in the pulmonary artery', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Regional Longitudinal Strain (Unitless)', 'timeFrame': '1 hour before start of operation until 21 hours after operation', 'description': 'Index of systolic function derived from single transthoracic echocardiographic (TTE) projection', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Regional Longitudinal Strain (Unitless)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Index of systolic function derived from single transthoracic echocardiographic (TTE) projection', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Regional Longitudinal Strain (Unitless)', 'timeFrame': '96 hours after operation until 6 months after operation', 'description': 'Index of systolic function derived from single transthoracic echocardiographic (TTE) projection', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Central Venous Pressure (mmHg)', 'timeFrame': '1 hour before operation until start of operation', 'description': 'Invasive measurement of pressure in the vena cava', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Central Venous Pressure (mmHg)', 'timeFrame': 'Start of operation until end of operation, approximately 3 hours', 'description': 'Invasive measurement of pressure in the vena cava', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Central Venous Pressure (mmHg)', 'timeFrame': 'End of operation until approx 4 hours after operation', 'description': 'Invasive measurement of pressure in the vena cava', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Central Venous Pressure (mmHg)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Invasive measurement of pressure in the vena cava', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Peak Systolic Velocity (m/s)', 'timeFrame': '1 hour before operation until 21 hours after operation', 'description': 'Tissue Doppler measure of systolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Peak Systolic Velocity (m/s)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Tissue Doppler measure of systolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Peak Systolic Velocity (m/s)', 'timeFrame': '96 hours after operation until 6 months after operation', 'description': 'Tissue Doppler measure of systolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)', 'timeFrame': '1 hour before operation until 21 hours after operation', 'description': 'Transthoracic echocardiographic measure of systolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Transthoracic echocardiographic measure of systolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)', 'timeFrame': '96 hours after operation until 6 months after operation', 'description': 'Transthoracic echocardiographic measure of systolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'E/A-ratio (Unitless)', 'timeFrame': '1 hour before operation until 21 hours after operation', 'description': 'Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'E/A-ratio (Unitless)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'E/A-ratio (Unitless)', 'timeFrame': '96 hours after operation until 6 months after operation', 'description': 'Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': "E'/A'-Ratio (Unitless)", 'timeFrame': '1 hour before operation until 21 hours after roperation', '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': "E'/A'-Ratio (Unitless)", 'timeFrame': '21 hours after operation until 96 hours after operation', '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': "E'/A'-Ratio (Unitless)", 'timeFrame': '96 hours after operation until 6 months after operation', '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Isovolumetric Relaxation Time (IVRT) (s)', 'timeFrame': '1 hour before operation until 21 hours after operation', 'description': 'Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Isovolumetric Relaxation Time (IVRT) (s)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Isovolumetric Relaxation Time (IVRT) (s)', 'timeFrame': '96 hours after operation until 6 months after operation', 'description': 'Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Ejection Fraction (Per Cent)', 'timeFrame': 'End of operation until approx. 4 hours after operation', 'description': 'Transeosophageal echocardiography: Measure of systolic function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Isovolumetric Relaxation Time (IVRT) (s)', 'timeFrame': 'End of operation until approx. 4 hours after operation', 'description': 'Transeosophageal echocardiography: Time from closure of aortic valve to opening of mitral valve. Measure of diastolic function.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Cardiac Index (l/Min/m2)', 'timeFrame': '1 hour before operation until start of operation', 'description': 'Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Cardiac Index (l/Min/m2)', 'timeFrame': 'Start of operation until end of operation, approximately 3 hours', 'description': 'Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Cardiac Index (l/Min/m2)', 'timeFrame': 'End of operation operation until approx. 4 hours after operation', 'description': 'Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Cardiac Index (l/Min/m2)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Inflammatory Parameters', 'timeFrame': '4 hours before operation until 21 hours after operation', 'description': 'Blood sample values of pro- and antiinflammatory mediators', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Inflammatory Parameters', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Blood sample values of pro- and antiinflammatory mediators', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'E/A-ratio (Transoesophageal)', 'timeFrame': 'from start of operation until end of operation, approximately 3 hours', 'description': 'Transoesophageal echocardiographic measure of diastolic heart function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'E/A-ratio (Transoesophageal)', 'timeFrame': 'from end of operation until approximately 4 hours after operation', 'description': 'Transoesophageal echocardiographic measure of diastolic heart function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Urine Clearance', 'timeFrame': 'from start of operation until 24 hours after operation', 'description': 'Urine analysis. Measure of kidney function.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Levosimendan', 'description': 'infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation\n\nlevosimendan: Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Identical placebo\n\nplacebo drug: Intravenous infusion, colour identical to levosimendan'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Levosimendan', 'description': 'infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation\n\nlevosimendan: Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Identical placebo\n\nplacebo drug: Intravenous infusion, colour identical to levosimendan'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000', 'lowerLimit': '69', 'upperLimit': '87'}, {'value': '73', 'groupId': 'BG001', 'lowerLimit': '73', 'upperLimit': '85'}, {'value': '74', 'groupId': 'BG002', 'lowerLimit': '69', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Terminated prematurely due to high incidence of postoperative atrial fibrillation.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-11', 'studyFirstSubmitDate': '2010-08-10', 'resultsFirstSubmitDate': '2018-05-11', 'studyFirstSubmitQcDate': '2010-08-24', 'lastUpdatePostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-11', 'studyFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "E/E'(Unitless)", 'timeFrame': '4 hours before operation until 21 hour after operation', 'description': "Ration between early transmitral flow (E) and mitral annular tissue velocity(E'). This ratio is an echocardiographic index of diastolic function"}], 'secondaryOutcomes': [{'measure': 'Isovolumetric Relaxation Time (IVRT) (s)', 'timeFrame': '4 hours before surgery until 1 hour before operation', 'description': 'Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function'}, {'measure': 'Ejection Fraction (Per Cent)', 'timeFrame': 'At start of operation until end of operation, approximately 3 hours', 'description': 'Transeosophageal echocardiography: Measure of systolic function'}, {'measure': 'Cardiac Index (l/Min/m2)', 'timeFrame': '4 hours before operation until 1 hour before operation', 'description': 'Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)'}, {'measure': 'Central Venous Pressure (mmHg)', 'timeFrame': '4 hours before operation until 1 hours before operation', 'description': 'Invasive measurement of pressure in the vena cava'}, {'measure': 'Pulmonary Artery Pressures (mmHg)', 'timeFrame': '4 hours before operation until 1 hour before operation', 'description': 'Invasive measurement of mean pressure in the pulmonary artery'}, {'measure': 'Systemic Arterial Pressure (mmHg)', 'timeFrame': '4 hours before operation until 1 hour before operation', 'description': 'Invasive measurements of arterial mean pressure'}, {'measure': 'N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)', 'timeFrame': '4 hours before operation until 4 hours after operation', 'description': 'blood sample reflecting stretch of the atrium/ventricle'}, {'measure': 'Troponin T (ug/l)', 'timeFrame': '4 hours before operation until 4 hours after operation', 'description': 'Blood sample expressing damage to the myocytes'}, {'measure': 'Lactate (mmol/l)', 'timeFrame': '4 hours before operation until 4 hour after operation', 'description': 'Arterial sampling of blood lactate'}, {'measure': 'Mixed Venous Oxygenation (Per Cent)', 'timeFrame': '4 hours before operation until 4 hour after operation', 'description': 'Oxygen content (per cent of hemoglobin saturated) of venous blood in pulmonary artery'}, {'measure': 'E/A Ratio (Unitless)', 'timeFrame': 'At the start of operation until the end of operationon, approximately 3 hours', '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'}, {'measure': 'Regional Longitudinal Strain (Unitless)', 'timeFrame': 'At the start of operation until the end of operation, approximately 3 hours', 'description': 'Transoesophageal echocardiographic (TEE) measure of systolic function. At this time not validated properly against acknowledged indices of systolic function.'}, {'measure': 'Need for Conventional Inotropical Agents', 'timeFrame': 'From start of operation until 5 days after operation', 'description': 'Conventional inotropics are comprised of all inotropics acting primarily through alfa- or beta- stimulation.'}, {'measure': 'Intravenous Fluid Requirement (l)', 'timeFrame': 'Within 24 hours from start of operation', 'description': 'Total volume of intravenous fluid required including blood products.'}, {'measure': 'Operation Time (Minutes)', 'timeFrame': 'From "knife start" until "knife end", approximately 3 hours'}, {'measure': 'Time on Heart-lung Machine (Minutes)', 'timeFrame': 'From time of cardioplegia until selfsufficient cardiac action, approximately 1 hour'}, {'measure': 'Intubation Time (Minutes)', 'timeFrame': 'From intubation until extubation, approximately 6 hours', 'description': 'Total time intubated including time of operation and in the intensive care ward'}, {'measure': 'Postoperative Admission Time at Intensive Care Unit (Hours)', 'timeFrame': 'From admission to the intensive care unit until discharge from intensive care unit, approximately 24 hours', 'description': 'Total admission time in the intensive care after operation'}, {'measure': 'No. of Patients With Adverse Events', 'timeFrame': '-4 hours until + 96 hours with respect to start of operation', 'description': 'Development of Ventricular tachycardia'}, {'measure': 'No. of Patients With Adverse Event', 'timeFrame': '-4 hours until + 96 hours with respect to start of operation', 'description': 'Development of atrial flutter/fibrillation'}, {'measure': 'No. of Patients With Adverse Event', 'timeFrame': '4 hours before operaton until 1 hour before operaton', 'description': 'Need for norepinephrine as an antagonist to the vasodilatatory effect of levosimendan'}, {'measure': 'No. of Patients With Adverse Event.', 'timeFrame': '4 hours before operation until 1 hour before operation', 'description': 'Occurence of nausea'}, {'measure': 'No. of Patients With Adverse Event', 'timeFrame': '4 hours before operation until approximately 1 hour before operation', 'description': 'Occurence of headache'}, {'measure': 'Regional Longitudinal Strain (Unitless)', 'timeFrame': '4 hours before until 1 hour before start of operation', 'description': 'Index of systolic function derived from single transthoracic echocardiographic (TTE) projection'}, {'measure': 'Ejection Fraction (Per Cent)', 'timeFrame': '1 hour before until 21 hour after start of operation', 'description': 'TTE: Index of systolic function'}, {'measure': 'Ejection Fraction (Per Cent)', 'timeFrame': '21 hours after operation until 96 hours after start of operation', 'description': 'TTE: Index of systolic function'}, {'measure': 'Ejection Fraction (Per Cent)', 'timeFrame': '96 hours after operation until 6 months after operation', 'description': 'TTE: Index of systolic function'}, {'measure': 'Regional Longitudinal Strain (Unitless)', 'timeFrame': 'Froml the end of operation until approx 4 hours after operation', 'description': 'Transoesophageal echocardiographic (TEE) measure of systolic function. At this time not validated properly against acknowledged indices of systolic function.'}, {'measure': 'E/A Ratio (Unitless)', 'timeFrame': 'At the end of operationon until approx 4 hours after operation', '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'}, {'measure': 'Left Ventricular Rotation (Degrees)', 'timeFrame': '96 hour after operation until 6 months after operation', 'description': 'TTE: Index of both systolic and diastolic function'}, {'measure': 'Mixed Venous Oxygenation (Per Cent)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Oxygen content (per cent of hemoglobin saturated) of venous blood in pulmonary artery'}, {'measure': 'Lactate (mmol/l)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Arterial sampling of blood lactate'}, {'measure': 'Troponin T (ug/l)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Blood sample expressing damage to the myocytes'}, {'measure': 'Troponin T (ug/l)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Blood sample expressing damage to the myocytes'}, {'measure': 'N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'blood sample reflecting stretch of the atrium/ventricle'}, {'measure': 'N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'blood sample reflecting stretch of the atrium/ventricle'}, {'measure': 'Systemic Arterial Pressure (mmHg)', 'timeFrame': '1 hour before operation until start of operation', 'description': 'Invasive measurements of arterial mean pressure'}, {'measure': 'Systemic Arterial Pressure (mmHg)', 'timeFrame': 'Start of operation until the end of operation, approximately 3 hours', 'description': 'Invasive measurements of arterial mean pressure'}, {'measure': 'Systemic Arterial Pressure (mmHg)', 'timeFrame': 'End of operation until approx 4 hours after operation', 'description': 'Invasive measurements of arterial mean pressure'}, {'measure': 'Systemic Arterial Pressure (mmHg)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Invasive measurements of arterial mean pressure'}, {'measure': 'Pulmonary Artery Pressures (mmHg)', 'timeFrame': '1 hour before operation until start of operation', 'description': 'Invasive measurement of mean pressure in the pulmonary artery'}, {'measure': 'Pulmonary Artery Pressures (mmHg)', 'timeFrame': 'Start of operation until end of operation, approximately 3 hours', 'description': 'Invasive measurement of mean pressure in the pulmonary artery'}, {'measure': 'Pulmonary Artery Pressures (mmHg)', 'timeFrame': 'End of operation until approx 4 hours after operation', 'description': 'Invasive measurement of mean pressure in the pulmonary artery'}, {'measure': 'Pulmonary Artery Pressures (mmHg)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Invasive measurement of mean pressure in the pulmonary artery'}, {'measure': 'Regional Longitudinal Strain (Unitless)', 'timeFrame': '1 hour before start of operation until 21 hours after operation', 'description': 'Index of systolic function derived from single transthoracic echocardiographic (TTE) projection'}, {'measure': 'Regional Longitudinal Strain (Unitless)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Index of systolic function derived from single transthoracic echocardiographic (TTE) projection'}, {'measure': 'Regional Longitudinal Strain (Unitless)', 'timeFrame': '96 hours after operation until 6 months after operation', 'description': 'Index of systolic function derived from single transthoracic echocardiographic (TTE) projection'}, {'measure': 'Central Venous Pressure (mmHg)', 'timeFrame': '1 hour before operation until start of operation', 'description': 'Invasive measurement of pressure in the vena cava'}, {'measure': 'Central Venous Pressure (mmHg)', 'timeFrame': 'Start of operation until end of operation, approximately 3 hours', 'description': 'Invasive measurement of pressure in the vena cava'}, {'measure': 'Central Venous Pressure (mmHg)', 'timeFrame': 'End of operation until approx 4 hours after operation', 'description': 'Invasive measurement of pressure in the vena cava'}, {'measure': 'Central Venous Pressure (mmHg)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Invasive measurement of pressure in the vena cava'}, {'measure': 'Peak Systolic Velocity (m/s)', 'timeFrame': '1 hour before operation until 21 hours after operation', 'description': 'Tissue Doppler measure of systolic function'}, {'measure': 'Peak Systolic Velocity (m/s)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Tissue Doppler measure of systolic function'}, {'measure': 'Peak Systolic Velocity (m/s)', 'timeFrame': '96 hours after operation until 6 months after operation', 'description': 'Tissue Doppler measure of systolic function'}, {'measure': 'Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)', 'timeFrame': '1 hour before operation until 21 hours after operation', 'description': 'Transthoracic echocardiographic measure of systolic function'}, {'measure': 'Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Transthoracic echocardiographic measure of systolic function'}, {'measure': 'Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)', 'timeFrame': '96 hours after operation until 6 months after operation', 'description': 'Transthoracic echocardiographic measure of systolic function'}, {'measure': 'E/A-ratio (Unitless)', 'timeFrame': '1 hour before operation until 21 hours after operation', 'description': 'Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.'}, {'measure': 'E/A-ratio (Unitless)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.'}, {'measure': 'E/A-ratio (Unitless)', 'timeFrame': '96 hours after operation until 6 months after operation', 'description': 'Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.'}, {'measure': "E'/A'-Ratio (Unitless)", 'timeFrame': '1 hour before operation until 21 hours after roperation', '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.'}, {'measure': "E'/A'-Ratio (Unitless)", 'timeFrame': '21 hours after operation until 96 hours after operation', '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.'}, {'measure': "E'/A'-Ratio (Unitless)", 'timeFrame': '96 hours after operation until 6 months after operation', '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.'}, {'measure': 'Isovolumetric Relaxation Time (IVRT) (s)', 'timeFrame': '1 hour before operation until 21 hours after operation', 'description': 'Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function'}, {'measure': 'Isovolumetric Relaxation Time (IVRT) (s)', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function'}, {'measure': 'Isovolumetric Relaxation Time (IVRT) (s)', 'timeFrame': '96 hours after operation until 6 months after operation', 'description': 'Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function'}, {'measure': 'Ejection Fraction (Per Cent)', 'timeFrame': 'End of operation until approx. 4 hours after operation', 'description': 'Transeosophageal echocardiography: Measure of systolic function'}, {'measure': 'Isovolumetric Relaxation Time (IVRT) (s)', 'timeFrame': 'End of operation until approx. 4 hours after operation', 'description': 'Transeosophageal echocardiography: Time from closure of aortic valve to opening of mitral valve. Measure of diastolic function.'}, {'measure': 'Cardiac Index (l/Min/m2)', 'timeFrame': '1 hour before operation until start of operation', 'description': 'Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)'}, {'measure': 'Cardiac Index (l/Min/m2)', 'timeFrame': 'Start of operation until end of operation, approximately 3 hours', 'description': 'Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)'}, {'measure': 'Cardiac Index (l/Min/m2)', 'timeFrame': 'End of operation operation until approx. 4 hours after operation', 'description': 'Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)'}, {'measure': 'Cardiac Index (l/Min/m2)', 'timeFrame': '4 hours after operation until 21 hours after operation', 'description': 'Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)'}, {'measure': 'Inflammatory Parameters', 'timeFrame': '4 hours before operation until 21 hours after operation', 'description': 'Blood sample values of pro- and antiinflammatory mediators'}, {'measure': 'Inflammatory Parameters', 'timeFrame': '21 hours after operation until 96 hours after operation', 'description': 'Blood sample values of pro- and antiinflammatory mediators'}, {'measure': 'E/A-ratio (Transoesophageal)', 'timeFrame': 'from start of operation until end of operation, approximately 3 hours', 'description': 'Transoesophageal echocardiographic measure of diastolic heart function'}, {'measure': 'E/A-ratio (Transoesophageal)', 'timeFrame': 'from end of operation until approximately 4 hours after operation', 'description': 'Transoesophageal echocardiographic measure of diastolic heart function'}, {'measure': 'Urine Clearance', 'timeFrame': 'from start of operation until 24 hours after operation', 'description': 'Urine analysis. Measure of kidney function.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['levosimendan', 'heart failure', 'inotropics', 'diastolic dysfunction', 'left ventricular hypertrophy', 'aortic valve stenosis'], 'conditions': ['Diastolic Dysfunction', 'Left Ventricular Hypertrophy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\n* Approximately 4 hours prior to surgery. Baseline. Start of levosimendan/placebo infusion\n* Immediately before surgery\n* After induction of anaesthesia and before "knife time" = start of surgery.\n* At the end of surgery: Levosimendan infusion will stop.\n* Approximately 4 hours after surgery immediately before extubation.\n* Approximately 21 hours after surgery\n* Approximately 96 hours after surgery (day 4)\n* 6 months after surgery\n\nOutcome measures are comprised of invasive measurements, blood samples, transthoracic echocardiography and transoesophageal echocardiography focusing on measures of systolic and diastolic function of the heart.\n\nInterim analysis will be conducted after 30 included patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible for aortic valve replacement\n* EF \\> 45%\n* Left ventricular posterior wall \\> 12mm\n* Sinus rhythm\n\nExclusion Criteria:\n\n* Concomitant bypass operation\n* Severe mitral insufficiency\n* Active endocarditis\n* Insufficient ultrasound opportunity\n* Systolic blood pressure \\< 100 mmHg\n* moderate-severe renal failure\n* allergy to levosimendan\n* lack of patient consent Pregnancy or status of lactating\n* Fertile women who do not use relevant anticonception'}, 'identificationModule': {'nctId': 'NCT01188369', 'briefTitle': 'Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Effects of Levosimendan on Systolic Deformation and Diastolic Function in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy', 'orgStudyIdInfo': {'id': '1616'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'levosimendan', 'description': 'infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation', 'interventionNames': ['Drug: levosimendan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Identical placebo', 'interventionNames': ['Drug: placebo drug']}], 'interventions': [{'name': 'levosimendan', 'type': 'DRUG', 'otherNames': ['Simdax'], 'description': 'Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation.', 'armGroupLabels': ['levosimendan']}, {'name': 'placebo drug', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Intravenous infusion, colour identical to levosimendan', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Århus N', 'state': 'Central Jutland', 'country': 'Denmark', 'facility': 'Department of Anaesthesiology'}], 'overallOfficials': [{'name': 'Peter Juhl-Olsen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}