Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-02-27 @ 10:06 AM
Study NCT ID:
NCT02892227
Status:
COMPLETED
Last Update Posted:
2025-12-01
First Post:
2016-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Acute Heart Failure: Contribution of Ultrasound Daily "in Bed Patient" Adjustment on Therapy With Impact Measure on re Hospital Rate During 30 Days
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2016-09-01', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rehospitalization', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '6 months'}, {'measure': 'worsening heart failure', 'timeFrame': 'during hospitalization'}, {'measure': 'average length of stay', 'timeFrame': 'during hospitalization'}, {'measure': 'alteration of biological parameters myocardial, kidney and liver', 'timeFrame': 'Hospital discharge +7 days, Hospital discharge +30 days'}]}, 'conditionsModule': {'keywords': ['bedside echography'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '35407655', 'type': 'RESULT', 'citation': 'Ricci JE, Aguilhon S, Occean BV, Soullier C, Solecki K, Robert C, Huet F, Cornillet L, Schmutz L, Chevallier T, Akodad M, Leclercq F, Cayla G, Lattuca B, Roubille F. Impact of Daily Bedside Echocardiographic Assessment on Readmissions in Acute Heart Failure: A Randomized Clinical Trial. J Clin Med. 2022 Apr 6;11(7):2047. doi: 10.3390/jcm11072047.'}]}, 'descriptionModule': {'briefSummary': "Our hypothesis: a daily bedside echocardiographic assessment, protocolized, simple and reproducible estimation of filling pressures with an evaluation of mitral inflow and the inferior vena cava, allow a more reliable estimate of the true blood volume of the patient and thus lead to a therapeutic adjustment more suitable.\n\nThis therapeutic adjustment closer to patient's needs would impact fewer readmissions at 30 days and mortality, less alteration of biological parameters myocardial, kidney and liver."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe patient or his representative must be given free and informed consent and signed consent.\n\n* The patient must be affiliated or beneficiary of a health insurance plan.\n* The patient is available for a follow-up 6 months.\n* The patient is of age or older (\\>) 18.\n* Patients hospitalized for acute heart failure who received at least 40mg of furosemide IV.\n* Patient with impaired LVEF \\<50%.\n* Patient with Nt-proBNP values\\> 1200pg / ml.\n\nExclusion Criteria:\n\n* The subject takes part in another study.\n\n * The subject is exclusion period determined by a previous study.\n * The subject is under judicial protection.\n * The subject or his representative refuses to sign the consent.\n * It is not possible to give the subject or his representative informed information.\n\nNon-inclusion criteria for those diseases or conditions associated (s) interfere (s):\n\n* The patient is pregnant or is breastfeeding.\n* The patient is already included in a surveillance program (PRADO, OSICAT).\n* Patient with a mechanical or biological mitral prosthesis.\n* History of mitral stenosis.\n* severe valvular surgery with maturity in months (\\<30 days).\n* chronic renal impairment on dialysis.\n* High grade AV block (AVB and BAV3 2/1).\n* Hypertrophic cardiomyopathy.\n* Cardiogenic shock.\n* Contraindications to furosemide.'}, 'identificationModule': {'nctId': 'NCT02892227', 'acronym': 'JECICA', 'briefTitle': 'Management of Acute Heart Failure: Contribution of Ultrasound Daily "in Bed Patient" Adjustment on Therapy With Impact Measure on re Hospital Rate During 30 Days', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'orgStudyIdInfo': {'id': 'AOI/2015/JER-01'}, 'secondaryIdInfos': [{'id': '2016-A00635-46', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JET ECHO', 'description': 'Transmitral flow estimation', 'interventionNames': ['Procedure: Transmitral flow estimation']}, {'type': 'NO_INTERVENTION', 'label': 'NO JET ECHO', 'description': 'no bedside echocardiography'}], 'interventions': [{'name': 'Transmitral flow estimation', 'type': 'PROCEDURE', 'description': 'Estimation of the transmitral flow of the inferior vena cava and its variations', 'armGroupLabels': ['JET ECHO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Arnaud de Villeneuve', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}