Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-25 @ 3:36 AM
Study NCT ID:
NCT02133105
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2014-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levosimendan Versus Dobutamine for Renal Function in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059347', 'term': 'Cardio-Renal Syndrome'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077464', 'term': 'Simendan'}, {'id': 'D004280', 'term': 'Dobutamine'}], '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'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2014-05-05', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in renal blood flow', 'timeFrame': '75 min minus baseline', 'description': 'Para-aminohippuric acid (PAH) infusion clearance'}, {'measure': 'Change in glomerular filtration rate', 'timeFrame': '75 min minus baseline', 'description': 'Chrome-ethylenediaminetetraacetic acid (EDTA) infusion clearance'}], 'secondaryOutcomes': [{'measure': 'Change in renal vascular resistance', 'timeFrame': '75 min minus baseline', 'description': 'Renal blood flow divided by the difference between renal arterial pressure and renal venous pressure'}, {'measure': 'Change in central hemodynamics', 'timeFrame': '75 min minus baseline', 'description': 'Right atrial pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, mean arterial pressure, cardiac output, pulmonary vascular resistance and systemic vascular resistance measured with a pulmonary artery thermodilution catheter.'}, {'measure': 'Change in renal oxygen consumption and oxygen extraction', 'timeFrame': '75 min minus baseline', 'description': 'Oxygen consumption: Renal blood flow multiplied by arterial-renal venous oxygen difference.\n\nOxygen extraction: Ratio of renal oxygen consumption to renal oxygen delivery'}, {'measure': 'Change in filtration fraction', 'timeFrame': '75 min minus baseline', 'description': 'Ratio of glomerular filtration rate to renal plasma flow'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart failure', 'Renal failure', 'Inotropic drugs', 'Levosimendan', 'Dobutamine'], 'conditions': ['Cardiorenal Syndrome']}, 'referencesModule': {'references': [{'pmid': '28785469', 'type': 'RESULT', 'citation': 'Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.'}, {'pmid': '16461840', 'type': 'RESULT', 'citation': 'Hillege HL, Nitsch D, Pfeffer MA, Swedberg K, McMurray JJ, Yusuf S, Granger CB, Michelson EL, Ostergren J, Cornel JH, de Zeeuw D, Pocock S, van Veldhuisen DJ; Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) Investigators. Renal function as a predictor of outcome in a broad spectrum of patients with heart failure. Circulation. 2006 Feb 7;113(5):671-8. doi: 10.1161/CIRCULATIONAHA.105.580506.'}, {'pmid': '15769768', 'type': 'RESULT', 'citation': 'Smith GL, Shlipak MG, Havranek EP, Masoudi FA, McClellan WM, Foody JM, Rathore SS, Krumholz HM. Race and renal impairment in heart failure: mortality in blacks versus whites. Circulation. 2005 Mar 15;111(10):1270-7. doi: 10.1161/01.CIR.0000158131.78881.D5.'}, {'pmid': '10889132', 'type': 'RESULT', 'citation': 'Hillege HL, Girbes AR, de Kam PJ, Boomsma F, de Zeeuw D, Charlesworth A, Hampton JR, van Veldhuisen DJ. Renal function, neurohormonal activation, and survival in patients with chronic heart failure. Circulation. 2000 Jul 11;102(2):203-10. doi: 10.1161/01.cir.102.2.203.'}, {'pmid': '30369310', 'type': 'DERIVED', 'citation': 'Lannemyr L, Ricksten SE, Rundqvist B, Andersson B, Bartfay SE, Ljungman C, Dahlberg P, Bergh N, Hjalmarsson C, Gilljam T, Bollano E, Karason K. Differential Effects of Levosimendan and Dobutamine on Glomerular Filtration Rate in Patients With Heart Failure and Renal Impairment:A Randomized Double-Blind Controlled Trial. J Am Heart Assoc. 2018 Aug 21;7(16):e008455. doi: 10.1161/JAHA.117.008455.'}]}, 'descriptionModule': {'briefSummary': 'Although inotropes have a favorable effect on central hemodynamics in patients with heart failure, their effect on renal hemodynamics is incompletely defined. The purpose of this study is to evaluate the efficacy of a 75 min intravenous infusion of levosimendan compared to a 75 min infusion of dobutamine on renal hemodynamics and function in patients with chronic heart failure and signs of cardiorenal syndrome. The investigators hypothesis is that patients treated with levosimendan will show greater increases in renal blood flow and glomerular filtration rate (GFR) than those treated with dobutamine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written, signed and dated informed consent\n* Male and Female subjects ≥18 years of age\n* Chronic congestive heart failure scheduled for right sided cardiac catheterization\n* Left ventricular ejection fraction ≤ 40% determined by echocardiography\n* Elevation of N Terminal-proBNP ≥ 500 ng/L\n* Cardiorenal syndrome (30ml/min ≤ estimated GFR ≤ 80 ml/min (MDRD)\n\nExclusion Criteria:\n\n* Acute heart failure, untreated\n* Systolic blood pressure \\< 80 mmHg\n* Tachycardia above 100 bpm\n* Angina Canadian Cardiovascular Society (CCS) class III or higher\n* Aortic stenosis\n* Hypertrophic cardiomyopathy\n* Restrictive cardiomyopathy\n* The presence of kidney disease diagnosed before heart failure\n* Administration of radiographic contrast \\< 1 week\n* Radiographic contrast allergy\n* In the Investigator's opinion, the patient has a clinically significant disease that could be adversely affected by study participation"}, 'identificationModule': {'nctId': 'NCT02133105', 'acronym': 'ELDOR', 'briefTitle': 'Levosimendan Versus Dobutamine for Renal Function in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'Efficacy of Intravenous Levosimendan Compared With Dobutamine on Renal Hemodynamics and Function in Chronic Heart Failure', 'orgStudyIdInfo': {'id': '2013-000986-36'}, 'secondaryIdInfos': [{'id': '2013-000986-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levosimendan', 'description': 'Levosimendan administration is initiated with a loading dose of 12μg/kg given over 10 min followed by a continuous infusion of 0.1 μg/kg/min for 65 min.', 'interventionNames': ['Drug: Levosimendan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dobutamine', 'description': 'Dobutamine is given as a continuous infusion without a bolus dose. The infusion rate is started at 5.0 μg/kg/min for 10 minutes, and thereafter increased to 7,5 μg/kg/min for 65 min.', 'interventionNames': ['Drug: Dobutamine']}], 'interventions': [{'name': 'Levosimendan', 'type': 'DRUG', 'otherNames': ['Simdax'], 'armGroupLabels': ['Levosimendan']}, {'name': 'Dobutamine', 'type': 'DRUG', 'otherNames': ['Dobutrex'], 'armGroupLabels': ['Dobutamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Kristjan Karason, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital, Department of Cardiology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}