Patients Hospitalized in Geriatrics for Heart FailureAGING HFNCT06377904
Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure (AGING HF Study (AGe and Heart Failure IN Geriatrics))
An observational study of Patients Hospitalized in Geriatrics for Heart Failure and Patients Aged 75 and Over, run by Gérond'if.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Patients Hospitalized in Geriatrics for Heart Failure, Patients Aged 75 and Over
- How many people
- 810 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Apr 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 75 and over hospitalized in geriatrics for heart failure
Who may be able to join
- Patients aged 75 and over Hospitalized in a geriatric ward with heart failure No oral opposition from patient
Who cannot join
- Patient under 75 years of age Patient not wishing to participate in the study Subject under guardianship/curatorship/supervision of justice
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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).
- Keywords
- Heart failure, Geriatrics, AGE
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical and therapeutic characteristics of elderly patients hospitalized in geriatrics for heart failure
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.
Measured: 36 months
Secondary outcomes (1)
Factors associated with patients hospitalization or rehospitalization
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Hospitalized in Geriatrics for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 810 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377904
- Sponsor's protocol ID
- 2023-A02125-40
- Acronym
- AGING HF
- Status last verified
- Mar 2024
- First submitted
- 17 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure
- ClinicalTrials.gov ID
- NCT06377904
- Acronym / sponsor ID
- AGING HF / 2023-A02125-40
- Keywords
- Heart failure, Geriatrics, AGE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 810 participants (estimated)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 75 and over hospitalized in geriatrics for heart failure
Key inclusion criteria (1 listed)
- Patients aged 75 and over Hospitalized in a geriatric ward with heart failure No oral opposition from patient
Key exclusion criteria (1 listed)
- Patient under 75 years of age Patient not wishing to participate in the study Subject under guardianship/curatorship/supervision of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Factors associated with patients hospitalization or rehospitalization
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Hospitalized in Geriatrics for Heart Failure and Patients Aged 75 and Over, run by Gérond'if.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle DUFOUR (+33 (01) 185 78 10 10, isabelle.dufour@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the clinical and therapeutic characteristics of elderly patients hospitalized in geriatrics for heart failure (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.