NCT04878263

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 28, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2023

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

May 4, 2021

Last Update Submit

April 10, 2026

Conditions

Heart Failure Acute

Keywords

Acute heart failureAt home hospitalizationCare pathwayNurseGeriatric assessmentSocial assessment

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (7)

  • FIL-EAS ic care pathway safety superiority

    6 months

  • Quality of life assessed by EQ-5D questionnaire

    6 months

  • Satisfaction assessed by QSH-37 questionnaire

    At the moment of patient initial discharge, up to 3 weeks

  • Cumulative number of days spent in hospital

    6 months

  • Impact on medical recommendation compliance

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR
Other: Conventional hospitalization

FIL-EAS ic group

EXPERIMENTAL
Other: FIL-EAS ic care pathway

Interventions

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.

Control group
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.

FIL-EAS ic group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Sainte Anne

Toulon, Var, 83000, France

Location

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83100, France

Location

Related Publications (1)

  • 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.

    PMID: 39454939BACKGROUND

Study Officials

  • Jean-Michel Tartière, MD

    Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 7, 2021

Study Start

June 28, 2021

Primary Completion

December 14, 2023

Study Completion

December 14, 2023

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)