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Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure (AGING HF Study (AGe and Heart Failure IN Geriatrics)) (AGING HF)

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ClinicalTrials.gov Identifier: NCT06377904
Recruitment Status : Not yet recruiting
First Posted : April 22, 2024
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Gérond'if

Study Description
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Brief Summary:
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.

Condition or disease
Patients Hospitalized in Geriatrics for Heart Failure Patients Aged 75 and Over

Detailed Description:

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:

  • Demographic data
  • History (comorbidities)
  • Type of heart disease
  • Frailty criteria
  • Clinical signs of heart failure
  • Geriatric syndromes (falls, cognitive disorders, (MMSE) confusion, malnutrition, loss of autonomy (ADL, IADL), bedsores)
  • Biology available (CBC, ionogram, creatinine, NT pro BNP, BHC, troponin, TSH, HBA1C)
  • ECG and echocardiography data
  • Treatment on admission, during stay and on discharge
  • Mode of discharge and length of stay
  • 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).
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 810 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure
Estimated Study Start Date : April 2024
Estimated Primary Completion Date : April 2027
Estimated Study Completion Date : April 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Retrospective phase
Retrospective inclusion (using data of patients who had been hospitalized between April 2020 and December 2023)
Prospective phase
Prospective inclusion (using data of patients hospitalized between January 2024 and August 2026)


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the clinical and therapeutic characteristics of elderly patients hospitalized in geriatrics for heart failure [ Time Frame: 36 months ]
    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.


Secondary Outcome Measures :
  1. Factors associated with patients hospitalization or rehospitalization [ Time Frame: 12 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 75 and over hospitalized in geriatrics for heart failure
Criteria

Inclusion Criteria:

  • Patients aged 75 and over Hospitalized in a geriatric ward with heart failure No oral opposition from patient

Exclusion Criteria:

  • Patient under 75 years of age Patient not wishing to participate in the study Subject under guardianship/curatorship/supervision of justice
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06377904


Contacts
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Contact: Isabelle DUFOUR +33 (01) 185 78 10 10 isabelle.dufour@gerondif.org
Contact: Prisca LUCAS, Project manager + 33 (01)85 78 10 10 prisca.lucas@gerondif.org

Sponsors and Collaborators
Gérond'if
More Information
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Responsible Party: Gérond'if
ClinicalTrials.gov Identifier: NCT06377904    
Other Study ID Numbers: 2023-A02125-40
First Posted: April 22, 2024    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gérond'if:
Heart failure
Geriatrics
AGE
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases