Heart Failure AcuteFIL-EASNCT04878263
Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients
A study testing Conventional hospitalization and FIL-EAS ic care pathway in people with Heart Failure Acute, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
Trial summary
Acute heart failure current management turns out to be a relative failure considering its elevated economical and human costs and the poor results obtained in terms of disease outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Acute
- What is being tested?
- Conventional hospitalization and FIL-EAS ic care pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Jun 2021to 14 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old hospitalized for acute heart failure
- Patient able to express his consent before participating in the study, certified by the caregiver if a written consent is not possible
- Patient able to follow protocol procedures, alone or with a caregiver help
- Caregiver consent to participate in the study and assist the patient during its own participation, if caregiver involvement is necessary
- Patient requiring an hospitalisation of at least 24 hours
- Patient covered by social security or equivalent regimen
- Patient having access to a mobile of fixed phone line
Who cannot join
- Admission in intensive care or resuscitation unit AND need for inotropic support, vasodilator, or invasive/non-invasive ventilation for the last 24h
- Renal insufficiency with CKD-EPI clearance inferior to 15 ml/min/1.73m2 since admission or dialysis
- Patient planned transfer to a rehabilitation and recuperative care facility (hospital or nursing home)
- Associated disease requiring frequent re-hospitalizations (cancer, dialysis, repeated sessions during planned hospitalizations)
- Associated disease with a high risk of death for the next 6 months
- Chronical respiratory insufficiency requiring daily invasive ventilation or a more than 3L/min permanent oxygen therapy
Show all 11Show fewer
- Patient suffering from severe dementia defined by a MMSE score ≤ 9
- Person participating in another research testing another care pathway
- Every other reason which, according to investigator, might interfere with study objective assessment
- Person under judicial protection measure (guardianship, curatorship)
- Person deprived of liberty by a judicial or administrative decision
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Sainte Anne
Toulon, Var, 83000
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83100
About this study
Acute heart failure current management turns out to be a relative failure considering its elevated economical and human costs and the poor results obtained in terms of disease outcome. Indeed this disease remains associated with a high rate of early re-hospitalizations and low adherence to therapeutic recommended settings and doses. Moreover, extra cardiological follow-up such as in social, geriatric or vaccination fields remain low compared to real needs.
Current recommendations incite health professionals to better define care pathways and to rationalize resources. Guidelines toward creation of hospitalization alternatives or limitation of time spent in hospital are given. In the same time, lack of cardiologic care management within heart failure patient care pathway is associated to poor prognosis and medical desertification as well as resource concentration on important health centers exacerbate this phenomenon. Innovative projects are then needed to improve patient care pathways, to open up areas without specialized health professionals and to rationalize care management by encouraging communication and skill exchange between hospitals and private practices.
FIL-EAS ic projet aims to compare a conventional care pathway in hospital with a follow up defined according to High Authority of Health recommendations to an organized care pathway favoring a short hospitalization (maximum of 4 working days) with early transition, when possible, to a medical and paramedical home care management with an approximately 10 day long combined follow up between hospital and private practices. This second care pathway should help to optimize therapeutics in home living conditions.
Read the detailed description
Acute heart failure current management turns out to be a relative failure considering its elevated economical and human costs and the poor results obtained in terms of disease outcome. Indeed this disease remains associated with a high rate of early re-hospitalizations and low adherence to therapeutic recommended settings and doses. Current recommendations incite health professionals to better define care pathways and to rationalize resources.
FIL-EAS ic projet aims to compare a conventional care pathway in hospital with a follow up defined according to High Authority of Health recommendations to an organized care pathway favoring a short hospitalization (maximum of 4 working days) with early transition, when possible, to a medical and paramedical home care management with an approximately 10 day long combined follow up between hospital and private practices.
Patients included in the study will be followed up for 6 months with one phone contact one month after hospital discharge, a second one two months later and one consultation 6 months after inclusion in the study.
- Conditions
- Heart Failure Acute
- Being tested
- Conventional hospitalization, FIL-EAS ic care pathway
- Keywords
- Acute heart failure, At home hospitalization, Care pathway, Nurse, Geriatric assessment, Social assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional hospitalizationOther
Conventional care pathway : patients will be hospitalized as long as necessary and then followed according to High Health Authorities recommendations and usual practices.
FIL-EAS ic care pathwayOther
Organized care pathway with a maximum 4 working day long conventional hospitalization followed by hospitalization at home with a follow up combining hospital and private practice competences.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Other: Conventional hospitalization |
| FIL-EAS ic group | Experimental | Not described Receives: Other: FIL-EAS ic care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIL-EAS ic care pathway safety non inferiority
Safety non inferiority will be assessed by comparing the proportion of patients deceased or with unplanned re-hospitalizations for heart failure within the 6 months following randomization between FIL-EAS ic care pathway and conventional hospitalization.
Measured: 6 months
Secondary outcomes (7)
FIL-EAS ic care pathway safety superiority
Safety superiority will be assessed by comparing the proportion of patients deceased or with unplanned re-hospitalizations for heart failure within the 6 months following randomization between FIL-EAS ic care pathway and conventional hospitalization.
Measured: 6 months
Quality of life assessed by EQ-5D questionnaire
Scores obtained after EQ-5D questionnaire completion will be collected during inclusion and research end visit. Evolution between these two scores will be compared between FIL-EAS ic care pathway and conventional hospitalization. EQ-5D questionnaire assess through 5 questions patient mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels : no problems, slight, moderate, severe and finally extreme problems. The patient is asked to tick the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The questionnaire records also patient's self-rated health on a vertical visual analogue scale going from 0 to 100. 0 corresponds to 'The worst health you can imagine' and 100 to 'The best health you can imagine'.
Measured: 6 months
Satisfaction assessed by QSH-37 questionnaire
Scores obtained after QSH-37 questionnaire completion will be collected during the visit performed at the end of initial hospitalization and compared between FIL-EAS ic care pathway and conventional hospitalization. The QSH-37 is composed of 37 questions about care management throughout patient hospitalization from the admission until patient's discharge and concerns following elements : relation with professionals (doctors, nurses, housekeepers), response delays, cleanliness, food and room equipment. For each item, possible answers go from "better than desired" to "extremely less than desired".
Measured: At the moment of patient initial discharge, up to 3 weeks
Cumulative number of days spent in hospital
The cumulative number of days spent in hospital within the 6 months following randomization will be compared between FIL-EAS ic care pathway and conventional hospitalization. In this calculation will be taken into account hospitalizations for acute care, hospitalizations for serious illnesses during their acute phases, mental health activities and non-ambulatory follow-up care and rehabilitation unit stays.
Measured: 6 months
Impact on medical recommendation compliance
Rate of prescription with percentage of recommended dose of heart failure treatments will be collected and compared between the two groups at initial hospitalization discharge and 6 months after. Rate of influenza, pneumococcal and Covid-19 vaccination, percentage of home therapeutic education use, percentage of ambulatory cardiovascular re-education use and rate of acute renal insufficiency occurrence during initial hospitalization will also be assessed.
Measured: 6 months
Geriatric evolution throughout care pathway
Scores obtained at 5 questionnaires will be collected during inclusion visit and research end visit. The evolution of these scores between these two time points will be compared between FIL-EAS ic care pathway and conventional hospitalization. These 5 questionnaires are : ADL (Activities of Daily Leaving), IADL(Instrumental Activities of Daily Leaving)-LAWTON, MNA (Mini Nutritional Assessment), mini GDS (Geriatric Depression Scale) and Dubois 5 words test. The two first asses the ability to perform daily activities. The third one aims at detecting malnutrition cases and is composed of 18 questions. Mini GDS, composed of 4 questions, detects depression cases and finally Dubois 5 words test is a tool evaluating patient cognitive functions. Besides these questionnaires, percentage of geriatric consultation occurrence throughout study participation will be compared between the two care pathways.
Measured: 6 months
Predictive value of biological analyses
Biological analyses results performed throughout study participation will be compared between FIL-EAS ic care pathway and conventional hospitalization and their predictive value with respect to the occurrence of unplanned re-hospitalizations for heart failure or deaths will be evaluated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start28 Jun 2021
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure AcuteStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- French Cardiology Society
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Tartière, MD, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878263
- Sponsor's protocol ID
- 2019-CHITS-04
- Other IDs
- 2020-A02939-30
- Acronym
- FIL-EAS
- Status last verified
- Jul 2026
- First submitted
- 4 May 2021
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tartiere JM, Candel J, Caignec ML, Jaunay L, Patin C, Kesri-Tartiere L, Esteveny M, Harel M, Derksen H, Quaino G, Lecardonnel I, Challal F, Armangaud P, Birgy C. Assessment of Noninferiority in Terms of 6-month Morbidity and Mortality Rates of a Hospital-at-home Care Pathway for Patients With Acute Heart Failure: FIL-EAS-ic Study Protocol. J Card Fail. 2025 Jun;31(6):928-938. doi: 10.1016/j.cardfail.2024.09.016. Epub 2024 Oct 23.
PubMed 39454939
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients
- ClinicalTrials.gov ID
- NCT04878263
- Acronym / sponsor ID
- FIL-EAS / 2019-CHITS-04
- Conditions
- Heart Failure Acute
- Keywords
- Acute heart failure, At home hospitalization, Care pathway, Nurse, Geriatric assessment, Social assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- French Cardiology Society
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 7 May 2021 (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.
Acute heart failure current management turns out to be a relative failure considering its elevated economical and human costs and the poor results obtained in terms of disease outcome. Indeed this disease remains associated with a high rate of early re-hospitalizations and low adherence to therapeutic recommended settings and doses. Moreover, extra cardiological follow-up such as in social, geriatric or vaccination fields remain low compared to real needs.
Current recommendations incite health professionals to better define care pathways and to rationalize resources. Guidelines toward creation of hospitalization alternatives or limitation of time spent in hospital are given. In the same time, lack of cardiologic care management within heart failure patient care pathway is associated to poor prognosis and medical desertification as well as resource concentration on important health centers exacerbate this phenomenon. Innovative projects are then needed to improve patient care pathways, to open up areas without specialized health professionals and to rationalize care management by encouraging communication and skill exchange between hospitals and private practices.
FIL-EAS ic projet aims to compare a conventional care pathway in hospital with a follow up defined according to High Authority of Health recommendations to an organized care pathway favoring a short hospitalization (maximum of 4 working days) with early transition, when possible, to a medical and paramedical home care management with an approximately 10 day long combined follow up between hospital and private practices. This second care pathway should help to optimize therapeutics in home living conditions.
Detailed description
Acute heart failure current management turns out to be a relative failure considering its elevated economical and human costs and the poor results obtained in terms of disease outcome. Indeed this disease remains associated with a high rate of early re-hospitalizations and low adherence to therapeutic recommended settings and doses. Current recommendations incite health professionals to better define care pathways and to rationalize resources.
FIL-EAS ic projet aims to compare a conventional care pathway in hospital with a follow up defined according to High Authority of Health recommendations to an organized care pathway favoring a short hospitalization (maximum of 4 working days) with early transition, when possible, to a medical and paramedical home care management with an approximately 10 day long combined follow up between hospital and private practices.
Patients included in the study will be followed up for 6 months with one phone contact one month after hospital discharge, a second one two months later and one consultation 6 months after inclusion in the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Conventional hospitalization |
| FIL-EAS ic group | Experimental | Other: FIL-EAS ic care pathway |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient over 18 years old hospitalized for acute heart failure
- Patient able to express his consent before participating in the study, certified by the caregiver if a written consent is not possible
- Patient able to follow protocol procedures, alone or with a caregiver help
- Caregiver consent to participate in the study and assist the patient during its own participation, if caregiver involvement is necessary
- Patient requiring an hospitalisation of at least 24 hours
Key exclusion criteria (11 listed)
- Admission in intensive care or resuscitation unit AND need for inotropic support, vasodilator, or invasive/non-invasive ventilation for the last 24h
- Renal insufficiency with CKD-EPI clearance inferior to 15 ml/min/1.73m2 since admission or dialysis
- Patient planned transfer to a rehabilitation and recuperative care facility (hospital or nursing home)
- Associated disease requiring frequent re-hospitalizations (cancer, dialysis, repeated sessions during planned hospitalizations)
- Associated disease with a high risk of death for the next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional hospitalizationConventional care pathway : patients will be hospitalized as long as necessary and then followed according to High Health Authorities recommendations and usual practices. | Other | Control group |
| FIL-EAS ic care pathwayOrganized care pathway with a maximum 4 working day long conventional hospitalization followed by hospitalization at home with a follow up combining hospital and private practice competences. | Other | FIL-EAS ic group |
Primary outcome
FIL-EAS ic care pathway safety non inferiority
Time frame: 6 months
Safety non inferiority will be assessed by comparing the proportion of patients deceased or with unplanned re-hospitalizations for heart failure within the 6 months following randomization between FIL-EAS ic care pathway and conventional hospitalization.
7 secondary outcomes
FIL-EAS ic care pathway safety superiority
Time frame: 6 months
Quality of life assessed by EQ-5D questionnaire
Time frame: 6 months
Satisfaction assessed by QSH-37 questionnaire
Time frame: At the moment of patient initial discharge, up to 3 weeks
Cumulative number of days spent in hospital
Time frame: 6 months
Impact on medical recommendation compliance
Time frame: 6 months
Geriatric evolution throughout care pathway
Time frame: 6 months
Predictive value of biological analyses
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 39454939Tartiere JM, Candel J, Caignec ML, Jaunay L, Patin C, Kesri-Tartiere L, Esteveny M, Harel M, Derksen H, Quaino G, Lecardonnel I, Challal F, Armangaud P, Birgy C. Assessment of Noninferiority in Terms of 6-month Morbidity and Mortality Rates of a Hospital-at-home Care Pathway for Patients With Acute Heart Failure: FIL-EAS-ic Study Protocol. J Card Fail. 2025 Jun;31(6):928-938. doi: 10.1016/j.cardfail.2024.09.016. Epub 2024 Oct 23.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jean-Michel Tartière, MD study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional hospitalization and FIL-EAS ic care pathway in people with Heart Failure Acute, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIL-EAS ic care pathway safety non inferiority (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04878263, which also lists 1 linked publication.
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 7 Jul 2026.