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

April 17, 2024 updated by: Gérond'if

Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

810

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 75 and over hospitalized in geriatrics for heart failure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gérond'if

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A02125-40

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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