Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-17 @ 4:46 PM
Study NCT ID:
NCT00527059
Status:
UNKNOWN
Last Update Posted:
2007-09-10
First Post:
2007-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D059347', 'term': 'Cardio-Renal Syndrome'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077464', 'term': 'Simendan'}, {'id': 'D013148', 'term': 'Spironolactone'}], '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': 'D007783', 'term': 'Lactones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2008-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-09-07', 'studyFirstSubmitDate': '2007-09-07', 'studyFirstSubmitQcDate': '2007-09-07', 'lastUpdatePostDateStruct': {'date': '2007-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary endpoint: GFR measured by inulin Clearance.', 'timeFrame': '0, 24. 48 and 72 hours after Levosimendan infusion starting'}], 'secondaryOutcomes': [{'measure': 'Secondary endpoints: •Other renal function measures: BUN, albumin, urine volume, sodium excretion and plasma sodium, and cystatin. •Hemodynamic parameters: PCWP, PAP, cardiac output, HR, BP, renal blood flow.', 'timeFrame': '0,1,24,48 and 72 hours after Levosimendan infusion started'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiorenal syndrome'], 'conditions': ['Heart Failure', 'Renal Insufficiency']}, 'referencesModule': {'references': [{'pmid': '24464960', 'type': 'DERIVED', 'citation': "Fedele F, Bruno N, Brasolin B, Caira C, D'Ambrosi A, Mancone M. Levosimendan improves renal function in acute decompensated heart failure: possible underlying mechanisms. Eur J Heart Fail. 2014 Mar;16(3):281-8. doi: 10.1002/ejhf.9. Epub 2013 Dec 11."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of levosimendan infusion, in addition to standard therapy,on renal function in patients with Acute Heart Failure,compared with standard therapy alone.', 'detailedDescription': 'The term "cardiorenal syndrome" has been applied to the presence or development of a renal dysfunction in HF patients and may be the major precipitant of decompensation and cause for admission in these patients. The renal hypoperfusion that occurs with cardiac injury can lead to sodium and water retention and activation of the renin-angiotensin-aldosterone system and neurohormonal pathways with resultant deleterious effects on the myocardium. A vicious cycle may then ensue and be associated with increased cardiovascular complications. In this regard, renal dysfunction is of a functional nature and thus means to intervene with this vicious cycle need to be sought.\n\nSeveral studies already demonstrated the deleterious effects of renal dysfunction on prognosis in patients with HF due to chronic left ventricular dysfunction.\n\nLevosimendan increases myocardial contractility without significant changes in the intracellular calcium ion and cyclic adenosine monophosphate concentrations and does not enhance myocardial oxygen demand. By its action on the potassium channels this drug also dilates the coronary and peripheral arteries and exerts an anti-ischemic,anti-stunning effect. To date, the effects of levosimendan on renal function in patients with worsening chronic HF, remain unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* an ejection fraction (EF) \uf0a340% by transthoracic echocardiogram,\n* a baseline pulmonary capillary wedge pressure (PCWP) \uf0b320 mm Hg\n* a MDRD (Modification of Diet Renal Disease) score \\> 30 and \\< 60\n* and a standard therapy for HF that should include angiotensin converting enzyme inhibitors, angiotensin receptor blockers, aldosterone blocking agents (spironolactone) and beta-blockers, unless contraindicated\n\nExclusion Criteria:\n\n* patients receiving other oral or i.v. inotropes,\n* oral or i.v. diuretics\n* or receiving nitroglycerine or nitroprusside,\n* patients with systolic blood pressure \\<110 mmHg,\n* mechanical ventilation,\n* anticipated survival \\<30 days,\n* absence of thoracic windows for echocardiography,\n* acute coronary syndromes,\n* sustained ventricular tachycardia or ventricular fibrillation,\n* documented renal artery stenosis, requiring dialysis,\n* requiring admission primarily for concurrent morbidity,\n* severe aortic or mitral regurgitation,\n* left ventricular failure primarily from uncorrected obstructive valvular disease, hypertrophic obstructive cardiomyopathy, restrictive/obstructive cardiomyopathy,\n* uncorrected thyroid disease,\n* known amyloid cardiomyopathy\n* or known malfunctioning artificial heart valve.'}, 'identificationModule': {'nctId': 'NCT00527059', 'briefTitle': 'Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure', 'orgStudyIdInfo': {'id': 'LEV1068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'patients with acute heart failure', 'interventionNames': ['Drug: Levosimendan in addition to standard therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'standard therapy for heart failure', 'interventionNames': ['Drug: spironolactone, beta-blockers,ecc']}], 'interventions': [{'name': 'Levosimendan in addition to standard therapy', 'type': 'DRUG', 'description': 'intravenous infusion of levosimendan (10 minutes bolus with 6 mcg/Kg according to physician judgement, followed by 0.1 mcg/Kg/min for 24 hours) in addition to standard therapy', 'armGroupLabels': ['1']}, {'name': 'spironolactone, beta-blockers,ecc', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Rome, Viale Del Policlinico 155', 'country': 'Italy', 'facility': 'Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Francesco Fedele, professor', 'role': 'CONTACT', 'email': 'francesco.fedele@uniroma1.it', 'phone': '0039-0649979020'}], 'overallOfficials': [{'name': 'Francesco Fedele, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}}}}