Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-01 @ 9:50 PM
Study NCT ID:
NCT06377904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure (AGING HF Study (AGe and Heart Failure IN Geriatrics))
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': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 810}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-04-17', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the clinical and therapeutic characteristics of elderly patients hospitalized in geriatrics for heart failure', 'timeFrame': '36 months', 'description': 'To Evaluate the clinical and therapeutic characteristics of elderly patients hospitalized in geriatrics for heart failure with 80% power and 5% alpha risk and expressed as a percentage.'}], 'secondaryOutcomes': [{'measure': 'Factors associated with patients hospitalization or rehospitalization', 'timeFrame': '12 months', 'description': "Quantitative data will be described as mean ± standard deviation. Qualitative variables will be expressed as percentages Statistical differences (hospitalized and/or deceased vs. non-rehospitalized and/or non-deceased patients) will be assessed using the Mann-Whitney U-test and Student's t-test for non-parametric and parametric continuous variables, respectively. Discrete variables will be normally distributed, and by the Mann-Whitney test for those not normally distributed. Survival curves will be drawn to analyze mortality and hospitalizations. Evaluated using the χ2 or Fisher test. Differences between groups will be assessed by ANOVA for the variables"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure', 'Geriatrics', 'AGE'], 'conditions': ['Patients Hospitalized in Geriatrics for Heart Failure', 'Patients Aged 75 and Over']}, 'descriptionModule': {'briefSummary': 'This retrospective (between April 2020 and December 2023) then prospective (between January 2024 and August 2026), non-interventional cohort study has as its main objective to evaluate the clinical and therapeutic characteristics of patients aged 75 and over hospitalized in geriatrics for heart failure and also to evaluate the clinical characteristics and triggering factor(s) of acute heart failure.', 'detailedDescription': 'Multicenter study, including patients aged 75 and over, hospitalized in geriatrics and having suffered heart failure in the geriatric wards of 3 centers. The following elements will be collected:\n\n* Demographic data\n* History (comorbidities)\n* Type of heart disease\n* Frailty criteria\n* Clinical signs of heart failure\n* Geriatric syndromes (falls, cognitive disorders, (MMSE) confusion, malnutrition, loss of autonomy (ADL, IADL), bedsores)\n* Biology available (CBC, ionogram, creatinine, NT pro BNP, BHC, troponin, TSH, HBA1C)\n* ECG and echocardiography data\n* Treatment on admission, during stay and on discharge\n* Mode of discharge and length of stay\n* Follow-up at 3, 6, 9 months and one year, through telephone calls with the patient, caregiver or attending physician. Questions will cover various aspects of health and quality of life, physical activity limitations, autonomy, symptoms, anxiety, depression, as well as neurocognitive status (using adapted questions).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 75 and over hospitalized in geriatrics for heart failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 75 and over Hospitalized in a geriatric ward with heart failure No oral opposition from patient\n\nExclusion Criteria:\n\n* Patient under 75 years of age Patient not wishing to participate in the study Subject under guardianship/curatorship/supervision of justice'}, 'identificationModule': {'nctId': 'NCT06377904', 'acronym': 'AGING HF', 'briefTitle': 'Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure (AGING HF Study (AGe and Heart Failure IN Geriatrics))', 'organization': {'class': 'OTHER', 'fullName': "Gérond'if"}, 'officialTitle': 'Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure', 'orgStudyIdInfo': {'id': '2023-A02125-40'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective phase', 'description': 'Retrospective inclusion (using data of patients who had been hospitalized between April 2020 and December 2023)'}, {'label': 'Prospective phase', 'description': 'Prospective inclusion (using data of patients hospitalized between January 2024 and August 2026)'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Isabelle DUFOUR', 'role': 'CONTACT', 'email': 'isabelle.dufour@gerondif.org', 'phone': '+33 (01) 185 78 10 10'}, {'name': 'Prisca LUCAS, Project manager', 'role': 'CONTACT', 'email': 'prisca.lucas@gerondif.org', 'phone': '+ 33 (01)85 78 10 10'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gérond'if", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}