Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01318460
Status:
COMPLETED
Last Update Posted:
2019-05-07
First Post:
2011-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Administration of Levosimendan in Patients Undergoing Coronary Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-04', 'studyFirstSubmitDate': '2011-03-17', 'studyFirstSubmitQcDate': '2011-03-17', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular function', 'timeFrame': 'Seventh postoperative day', 'description': 'Left ventricular function as assessed by transthoracic or transesophageal echocardiography on the seventh postoperative day'}], 'secondaryOutcomes': [{'measure': 'Perioperative mortality', 'timeFrame': '30 days postoperatively'}, {'measure': 'Need for intraaortic balloon pump', 'timeFrame': '1st-7th postoperative day'}, {'measure': 'Inotropic support', 'timeFrame': '1st-7th postoperative day', 'description': 'Need for high inotropic support'}, {'measure': 'Total ICU stay', 'timeFrame': '1st-7th postoperative day'}, {'measure': 'Total length of hospital stay', 'timeFrame': '1st-7th postoperative day'}, {'measure': 'Time on mechanical ventilation', 'timeFrame': '1st-7th postoperative day'}, {'measure': 'Major adverse cardiovascular events', 'timeFrame': '1st-7th postoperative day', 'description': 'Perioperative myocardial infarction, stroke, need for revascularization)'}, {'measure': 'Morbidity', 'timeFrame': '1st-7th postoperative day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'levosimendan', 'coronary artery bypass grafting', 'cardiac surgery'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '17377079', 'type': 'BACKGROUND', 'citation': 'De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. doi: 10.1213/01.ane.0000256863.92050.d3.'}, {'pmid': '17702589', 'type': 'BACKGROUND', 'citation': 'Tasouli A, Papadopoulos K, Antoniou T, Kriaras I, Stavridis G, Degiannis D, Geroulanos S. Efficacy and safety of perioperative infusion of levosimendan in patients with compromised cardiac function undergoing open-heart surgery: importance of early use. Eur J Cardiothorac Surg. 2007 Oct;32(4):629-33. doi: 10.1016/j.ejcts.2007.07.010. Epub 2007 Aug 15.'}, {'pmid': '19592266', 'type': 'BACKGROUND', 'citation': 'Kolseth SM, Nordhaug DO, Stenseth R, Sellevold O, Kirkeby-Garstad I, Wahba A. Prophylactic treatment with levosimendan: a retrospective matched-control study of patients with reduced left ventricular function. Eur J Cardiothorac Surg. 2009 Dec;36(6):1024-30. doi: 10.1016/j.ejcts.2009.05.001. Epub 2009 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'The present pilot study aims to investigate the effectiveness of the preoperative infusion of levosimendan in patients with impaired left ventricular function undergoing coronary artery bypass grafting.', 'detailedDescription': 'Myocardial revascularization in patients with impaired left ventricular function remains a serious problem in cardiac surgery. Despite the recent developments with the use of new surgical techniques (mini-extracorporeal circulation, off pump surgery) the perioperative morbidity and mortality are relatively high. Therapeutic solutions with the use of inotropic drugs, as adrenergic agonists and phosphodiesterase inhibitors, have offered important improvement to the hemodynamic status of these patients, but they have not considerably decreased mortality. These drugs owe their positive inotropic action to the increase of intracellular calcium and thereafter they improve the myocardial function.\n\nLevosimendan (SIMDAX) is a new calcium sensitizer which increases the myocardial contractility without particular promotion of the intracellular calcium accumulation. Contemporary experimental and clinical data demonstrated the effectiveness of this drug in the reduction of surgical mortality to the patients with low left ventricular ejection fraction (LVEF) who undergo coronary artery bypass grafting (CABG).\n\nThis is an original prospective randomized controlled study focused on the preoperative use of this drug in patients with impaired left ventricular function which is associated with a high operative risk (i.e. EuroSCORE). Perioperative myocardial stunning is particularly evident in this cohort of patients. Prophylactic administration of levosimendan the day before the operation could be translated in improved myocardial performance intraoperatively and during the early postoperative period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* coronary artery disease which warrants myocardial revascularization with coronary artery bypass grafting according to current guidelines\n* age \\< 79 years old\n* left ventricular ejection fraction \\<= 40%\n* informed patient's consent\n\nExclusion Criteria:\n\n* age \\< 18 years old\n* emergency surgery\n* medical history of acute myocardial infarction with ST elevation (STEMI) less than 14 days old\n* any severe comorbidity which increases the perioperative risk (i.e. neoplasia, rheumatoid arthritis, chronic obstructive pulmonary disease)\n* need for valvular replacement surgery\n* redo surgery\n* serum creatinine \\> 2 mg/dl\n* history of malignant cardiac arrhythmias"}, 'identificationModule': {'nctId': 'NCT01318460', 'briefTitle': 'Prophylactic Administration of Levosimendan in Patients Undergoing Coronary Surgery', 'organization': {'class': 'OTHER', 'fullName': 'AHEPA University Hospital'}, 'officialTitle': 'Prophylactic Administration of Levosimendan in Patients With Impaired Left Ventricular Function Undergoing Coronary Surgery', 'orgStudyIdInfo': {'id': 'AHEPA_CTS-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levosimendan', 'description': 'Patients treated with prophylactic administration of levosimendan', 'interventionNames': ['Drug: Levosimendan infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Patients managed with placebo administration', 'interventionNames': ['Drug: Placebo infusion']}], 'interventions': [{'name': 'Levosimendan infusion', 'type': 'DRUG', 'description': 'Prophylactic 24h infusion of levosimendan at a dose of 0.1 mg/kg/min', 'armGroupLabels': ['Levosimendan']}, {'name': 'Placebo infusion', 'type': 'DRUG', 'description': 'Twenty-four hour administration of placebo', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '546 36', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Department of Cardiothoracic Surgery, AHEPA University Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Kyriakos Anastasiadis, MD, FETCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AHEPA University Hospital'}, {'name': 'Christos Papakonstantinou, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AHEPA University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AHEPA University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiothoracic Department', 'investigatorFullName': 'Kyriakos Anastasiadis', 'investigatorAffiliation': 'AHEPA University Hospital'}}}}