Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-31 @ 8:55 PM
Study NCT ID:
NCT04984928
Status:
UNKNOWN
Last Update Posted:
2022-04-12
First Post:
2021-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Readmission Risk of Patients With Heart Failure.
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-07-29', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30 days all cause readmission rate', 'timeFrame': 'day 30', 'description': '30 days all cause readmission rate'}], 'secondaryOutcomes': [{'measure': '90 days all cause readmission rate', 'timeFrame': 'day 90', 'description': '90 days all cause readmission rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure', 'Prediction', 'Personnalized medicine'], 'conditions': ['Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'Heart failure (HF) is a frequent, serious, and costly chronic disease: it leads to 150,000 hospitalizations each year in France at a cost of 525 million Euros.\n\nIt is estimated that 20-40% of these hospitalizations are preventable by known interventions: home telemonitoring, care coordination, therapeutic intensification and therapeutic education. But these interventions only work if patients at high risk of rehospitalization are targeted to individualize management. In these patients, the risk of rehospitalization depends on clinical, biological, socioeconomic, care pathway, and location-related data. Existing predictive tools perform poorly due to three important limitations: non-use of unstructured clinical data, lack of integration of multimodal data, and weakness of the algorithmic approach.\n\nThe objective is to design and validate a predictive algorithm for the risk of rehospitalization in heart failure patients, using multiple data sources'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Heart failure patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* All consecutive adults\n* Admitted to Montpellier University Hospital in 2017-2020\n* For heart failure\n\nExclusion criteria:\n\n\\- age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT04984928', 'acronym': 'PREDIC', 'briefTitle': 'Readmission Risk of Patients With Heart Failure.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Predicting the Risk of Readmission in Patients With Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'RECHMPL21_0488'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Grégoire MERCIER, PUPH', 'role': 'CONTACT', 'email': 'g-mercier@chu-montpellier.fr', 'phone': '4 67 33 91 09', 'phoneExt': '33'}], 'facility': 'Uh Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Grégoire Mercier, PU PH', 'role': 'CONTACT', 'email': 'g-mercier@chu-montpellier.fr', 'phone': '4 67 33 91 09', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Grégoire Mercier, PU PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}