Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-30 @ 4:58 PM
Study NCT ID:
NCT04252404
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2020-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FranceLEVO - Zimino Registry (FZR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002303', 'term': 'Cardiac Output, Low'}, {'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-08', 'size': 404622, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-15T05:10', 'hasProtocol': True}, {'date': '2019-11-08', 'size': 347644, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-01-29T07:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-31', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Indication for levosimendan (Zimino)', 'timeFrame': 'from January 28, 2020 until January 28, 2021', 'description': 'Physicians will be requested to choose one of the following indications (pop-up list):\n\n1. Cardiogenic shock (medical setting or post cardiac surgery)\n2. Heart failure decompensation (medical, setting)\n3. Low cardiac output syndrome (post cardiac surgery)\n4. Heart failure decompensation in a patient receiving beta-blockers\n5. ECMO weaning\n6. Repetitive use in a patient with end-stage heart failure\n7. Other (text)'}, {'measure': 'Dose of levosimendan (Zimino) (in µg/kg/min)', 'timeFrame': 'from January 28, 2020 until January 28, 2021', 'description': 'Physicians will be requested to describe the levosimendan regimen used:\n\nA) Loading dose (in µg/kg) B) Dose of the continuous infusion (in µg/kg/min)'}, {'measure': 'Duration of levosimendan (Zimino) infusion', 'timeFrame': 'from January 28, 2020 until January 28, 2021', 'description': 'Number of hours during which the patient received levosimendan'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low cardiac output syndrome', 'cardiogenic shock'], 'conditions': ['Acute Heart Failure']}, 'descriptionModule': {'briefSummary': 'The French National Authority for Health (Haute Autorité de santé) requested a registry study to obtain post-market surveillance data to describe baseline clinical profiles, management and outcome of patients treated with Zimino®. This study is designed to provide real-life data on the use, safety and clinical outcomes of Zimino® in routine clinical practice in France.', 'detailedDescription': "This is a real-life, non-interventional, observational, multicentre study in all patients (including children) receiving Zimino® in France.\n\nThe patients will be evaluated during the index hospitalisation and on follow-up days 30 (±15) and 90 (±15) after hospital discharge. The follow-up can be a phone call or a visit to the hospital. Patients who meet the eligibility criteria will be identified consecutively at each hospital. The participating hospitals will vary in size and medical activities, depending on their location and the population size they serve.\n\nThe physician will determine the patient's treatment strategy. Drug prescriptions and the indications to perform diagnostic or therapeutic procedures will be left completely to the discretion of the physicians.\n\nThe estimated enrollment period is 12 months (enrollment of the first patient - enrollment of the last patient), or less if the cohort (n=600) is completed earlier, and the maximum total data collection period is 15 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cardiac dysfunction receiving levosimendan (Zimino®)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients receiving Zimino® treatment\n* Patients or patient's families not objecting to the patient's participation in the study.\n\nExclusion Criteria:\n\n* None"}, 'identificationModule': {'nctId': 'NCT04252404', 'acronym': 'FZR', 'briefTitle': 'FranceLEVO - Zimino Registry (FZR)', 'organization': {'class': 'OTHER', 'fullName': 'Arcothova'}, 'officialTitle': 'FranceLEVO - Zimino® Registry: a French Registry Evaluating the Use of Levosimendan (Zimino®)', 'orgStudyIdInfo': {'id': 'Arcothova'}}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou, AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Bernard CHOLLEY, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arcothova'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will remain with the sponsor (Arcothova)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arcothova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinating Investigator', 'investigatorFullName': 'Cholley Bernard', 'investigatorAffiliation': 'Arcothova'}}}}