Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT00324766
Status:
COMPLETED
Last Update Posted:
2012-06-26
First Post:
2006-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levosimendan in Acute Heart Failure Following Acute Myocardial Infarction.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-25', 'studyFirstSubmitDate': '2006-05-10', 'studyFirstSubmitQcDate': '2006-05-10', 'lastUpdatePostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: Changes in regional contractility measured as wall-motion score index, proBNP and clinical symptoms.', 'timeFrame': 'At 5 days', 'description': 'Changes in regional contractility (WMSI) measured by echo is the primary endpoint in the study and the sample size calculation is based on expected differenced in WMSI from baseline to day 5 between groups.'}], 'secondaryOutcomes': [{'measure': 'Mace: Time to death, non-fatal myocardial infarction or revascularization during the first 6 weeks and 6 months.', 'timeFrame': '6 months'}, {'measure': 'Time to rehospitalisation for decompensated heart failure.', 'timeFrame': '6 months'}, {'measure': 'Days hospitalised/days in intensive/coronary care.', 'timeFrame': 'At discharge'}, {'measure': 'Changes in inflammation markers.', 'timeFrame': '1, 5 days, 6 weeks.'}, {'measure': 'Improvement in creatinine clearance.', 'timeFrame': '5 days'}, {'measure': 'Improvement of hemodynamic parameters.', 'timeFrame': '5 days'}, {'measure': 'Central venous oxygen saturation.', 'timeFrame': '1 day'}, {'measure': 'Total mortality.', 'timeFrame': '6 months'}, {'measure': 'Arrhythmias, hypotension, ischaemic episodes.', 'timeFrame': '5 days'}, {'measure': 'Change in proBNP', 'timeFrame': 'Baseline to day 5'}, {'measure': 'Change in clinical symptom score', 'timeFrame': 'Baseline to day 5'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Myocardial Infarction', 'Heart Failure', 'Cardiogenic Shock']}, 'referencesModule': {'references': [{'pmid': '33119664', 'type': 'DERIVED', 'citation': 'Langseth MS, Andersen GO, Husebye T, Arnesen H, Zucknick M, Solheim S, Eritsland J, Seljeflot I, Opstad TB, Helseth R. Neutrophil extracellular trap components and myocardial recovery in post-ischemic acute heart failure. PLoS One. 2020 Oct 29;15(10):e0241333. doi: 10.1371/journal.pone.0241333. eCollection 2020.'}, {'pmid': '25390695', 'type': 'DERIVED', 'citation': 'Husebye T, Eritsland J, Arnesen H, Bjornerheim R, Mangschau A, Seljeflot I, Andersen GO. Association of interleukin 8 and myocardial recovery in patients with ST-elevation myocardial infarction complicated by acute heart failure. PLoS One. 2014 Nov 12;9(11):e112359. doi: 10.1371/journal.pone.0112359. eCollection 2014.'}, {'pmid': '23288914', 'type': 'DERIVED', 'citation': 'Husebye T, Eritsland J, Muller C, Sandvik L, Arnesen H, Seljeflot I, Mangschau A, Bjornerheim R, Andersen GO. Levosimendan in acute heart failure following primary percutaneous coronary intervention-treated acute ST-elevation myocardial infarction. Results from the LEAF trial: a randomized, placebo-controlled study. Eur J Heart Fail. 2013 May;15(5):565-72. doi: 10.1093/eurjhf/hfs215. Epub 2013 Jan 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of a 24 hour infusion with levosimendan in patients with acute myocardial infarction and heart failure after acute percutaneous coronary intervention (PCI) treatment.', 'detailedDescription': 'Double blind placebo-controlled study with parallel groups in patients with acute PCI treated myocardial infarction complicated with decompensated heart failure. The study include a prospectively defined subgroup of patients in cardiogenic shock. Treating acute myocardial infarction with PCI restores blood flow, but decreased contractility remains for hours and days due to stunned myocardium. Levosimendan has both inotropic and vasodilatory effects which could support the failing heart after treating the acute myocardial infarction with PCI and may improve myocardial stunning and decrease pro-inflammatory cytokines. Levosimendan could improve myocardial contractility, symptoms and outcome without adverse effects. The aims of the study are to investigate whether a 24 hour infusion with levosimendan could improve regional contractility measured by echocardiography, improve BNP levels, reduce the levels of pro-inflammatory cytokines and improve symptoms in patients with acute decompensated heart failure during the first 24 hours after acute PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute ST-elevation myocardial infarction subject to acute PCI or non-ST elevation myocardial infarction subject to PCI within 72 hours after start of chest pain and:\n* Revascularization by PCI,\n* Signs of decreased wall-motion in at least 3 of 16 segments of the left ventricle\n* Dyspnoea at rest and one of the following:\n\npulmonary edema, pulmonary congestion,need for CPAP or ventilator, need for IC diuretics or oliguria.\n\nSubgroup of patients in cardiogenic shock: Systolic BP below 90 after 1 hour of volume therapy.\n\nExclusion Criteria:\n\n* Age below 20 years\n* Heart rate above 120 bpm\n* Septic shock\n* ARDS\n* Creatinine \\>450 micromol/l\n* Hepatic impairment\n* Significant mechanical outlet obstruction\n* Allergy against study drug medication\n* Anaemia (Hb \\<8 g/dl)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00324766', 'briefTitle': 'Levosimendan in Acute Heart Failure Following Acute Myocardial Infarction.', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Safety and Efficacy of Levosimendan in Patients With Acute Myocardial Infarction Complicated by Symptomatic Left Ventricular Failure.', 'orgStudyIdInfo': {'id': '0105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'levosimendan', 'interventionNames': ['Drug: levosimendan']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo, 1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min', 'interventionNames': ['Drug: placebo,']}], 'interventions': [{'name': 'levosimendan', 'type': 'DRUG', 'otherNames': ['Simdax'], 'description': '1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min', 'armGroupLabels': ['1']}, {'name': 'placebo,', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': '24 h, infusion', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-0852', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Department of Cardiology, Ulleval University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Trygve Husebye, MD,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Ulleval University Hospital'}, {'name': 'Geir Ø Andersen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Cardiology, Ulleval University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}