Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT01221116
Status:
TERMINATED
Last Update Posted:
2010-11-02
First Post:
2010-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'The study was stopped due to difficulties in including patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-01', 'studyFirstSubmitDate': '2010-10-13', 'studyFirstSubmitQcDate': '2010-10-13', 'lastUpdatePostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for inotropic agents or IABP (intra aortal balloon pump)', 'timeFrame': 'jan 2003 - dec 2008'}], 'secondaryOutcomes': [{'measure': 'Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data.', 'timeFrame': 'jan 2003-dec 2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coronary artery disease,', 'aortic stenosis,', 'heart failure'], 'conditions': ['Heart Failure', 'Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit', 'detailedDescription': 'Single center, prospective, randomized parallel-group, double-blinded study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EF (ejection fraction)\\<40%\n\nExclusion Criteria:\n\n* renal failure, liver failure'}, 'identificationModule': {'nctId': 'NCT01221116', 'briefTitle': 'Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ullevaal University Hospital'}, 'officialTitle': 'Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery', 'orgStudyIdInfo': {'id': 'INSI-study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1: Type of surgery', 'description': 'Two types of patients are compared (placebo vs levosimendan): CABG - coronary artery bypass grafting and AVR - aortic valve replacement (either with or without CABG - coronary artery bypass grafting)', 'interventionNames': ['Drug: levosimendan']}], 'interventions': [{'name': 'levosimendan', 'type': 'DRUG', 'otherNames': ['Type of surgery'], 'description': 'levosimendan 0.1 microgram/kg/min) for 24 hours', 'armGroupLabels': ['1: Type of surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0407', 'city': 'Oslo', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Knut A Kirkebøen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ullevaal University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ullevaal University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ullevaal University Hospital', 'oldOrganization': 'Knut Arvid Kirkebøen'}}}}