Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT02880358
Status:
UNKNOWN
Last Update Posted:
2016-08-26
First Post:
2013-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology and Prognostic of the Acute Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA, serum, whole blood and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-23', 'studyFirstSubmitDate': '2013-07-31', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effectiveness of therapeutic strategies on survival', 'timeFrame': 'Inclusion, 6 months, 1, 2, and 3 years after acute heart failure', 'description': 'Patient medical record data (treatment, support network, therapeutic education)'}], 'primaryOutcomes': [{'measure': 'Incidence of Acute Heart Failure', 'timeFrame': 'Inclusion'}], 'secondaryOutcomes': [{'measure': 'Morbi-mortality of patients presenting an acute heart failure', 'timeFrame': 'Inclusion, 6 month, 1, 2 and 3 years after acute heart failure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Decompensated Chronic Heart Failure', 'Heart Failure NYHA Class III', 'Acute Pulmonary Edema', 'Cardiogenic Shock', 'Heart Failure NYHA Class IV']}, 'referencesModule': {'references': [{'pmid': '30972619', 'type': 'DERIVED', 'citation': 'Al-Gobari M, Agrinier N, Soudant M, Burnand B, Thilly N. Effects of Statins to Reduce All-Cause Mortality in Heart Failure Patients: Findings from the EPICAL2 Cohort Study. Am J Cardiovasc Drugs. 2019 Oct;19(5):497-508. doi: 10.1007/s40256-019-00346-4.'}]}, 'descriptionModule': {'briefSummary': "EPICAL 2 (Epidemiology and prognostic of the Acute Heart Failure) is an epidemiological, observational, prospective and multicenter study. This study includes at first an exhaustive recording of the cases on a geographic area at East of France, then the recorded patients are followed up in a cohort at least 3 years. This study follows the experiences of the EPICAL study led by our team.\n\nMain objective: To describe the characteristics of the patients affected by acute heart failure and to identify prognostic factors, in particular related to care. More exactly :\n\n* To describe the sociodemographic, clinical, biological and therapeutic characteristics of the patients presenting an acute heart failure during hospitalisation and living at East of France ;\n* To study the short and medium-term morbi-mortality of these patients, and identify the main factors determining the prognosis for survival ;\n* To evaluate the prognostic impact of the intra and extra-hospital care ;\n* To identify the evolution of the care's practices of the decompensated heart failure since the EPICAL study (15 years) and their influence on the prognosis of the disease.\n\nSecondary objective: to constitute a biological collection of serum, plasma and urine of patients' sample presenting an acute heart failure.", 'detailedDescription': 'Criteria of inclusion:\n\n* Patients hospitalized for acute heart failure or developing an acute heart failure during the hospitalisation in the intensive care, cardiology or geriatrics departments of the hospitals of Northeast of France during one year\n* Patients died in emergencies or during the transfer, with a diagnosis of acute heart failure.\n\nAcute heart failure includes decompensation of chronic heart failure, advanced stage of the heart failure, acute oedema of the lung and cardiogenic shock. According to the data of registers, the incidence of the acute heart failure in approximately 2,5 cases per 1000 adults per year, the expected sample size amounts to 2500 eligible patients over 1 year.\n\nData collection: the doctors declare the Acute Heart Failure of their departments. The technicians of clinical research collect the data concerning the sociodemographic, clinical, biological and therapeutic characteristics of the inclusive patients on arrival at the hospital, during the hospitalisation and at the exit. The biological takings are made for the patients having given their consent before the exit of the hospitalization. The patients are followed up during 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized for acute heart failure or developing an acute heart failure during the hospitalisation. It is an exhaustive recruitment in a region of Northeast of France. So, there is no sampling', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Patients hospitalized for acute heart failure or developing an acute heart failure during the hospitalisation in the intensive care, cardiology or geriatrics departments of the hospitals of Northeast of France during one year\n* Patients died in emergencies or during the transfer, with a diagnosis of acute heart failure.'}, 'identificationModule': {'nctId': 'NCT02880358', 'acronym': 'EPICAL2', 'briefTitle': 'Epidemiology and Prognostic of the Acute Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Epidemiology and Prognostic of the Acute Heart Failure in Northeast of France', 'orgStudyIdInfo': {'id': '911069'}}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'state': 'Lorraine', 'country': 'France', 'facility': 'University Hospital Center', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Nathalie Thilly, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '¹ INSERM, CIC-EC, CIE6, Nancy, F-54 000, France ² CHU Nancy, Epidémiologie et Evaluation Cliniques, Nancy, F-54 000, France ³ Université de Lorraine, CIC-EC, CIE 6, Nancy, F-54 000, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}