Nurse-led Consultations in Heart Failure Within the 'FIL-EAS' Evaluation and Support Care Pathway for Heart Failure Patients (ISPIC FILEAS)

April 10, 2026 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

The management of chronic heart failure, following current guidelines, requires the implementation and adjustment of therapies to limit mortality and morbidity associated with disease progression. However, this period of treatment titration remains challenging due to the need for multiple, closely spaced consultations. The difficulty in maintaining this consultation frequency, coupled with the current decline in medical demographics, largely explains the lack of treatment titration or even initiation and the existing therapeutic inertia. Concurrently, medical telemonitoring is emerging as an essential tool in heart failure management, offering significant benefits for both patients and healthcare professionals.

In this context, new forms of nursing practices have emerged, such as advanced practice nursing, aimed at improving the care of patients with chronic diseases. However, only limited data are currently available regarding the functioning and impact of these consultations in France.

The "Evaluation and Support Pathway for Heart Failure Patients (FIL-EAS ic)" has systematically integrated this new model of consultations provided by heart failure nurse specialists. Given their significant and growing role within the pathway, it appears necessary to thoroughly evaluate these consultations to propose improvements and maximize their effectiveness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

137

Contacts and Locations

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

Study Locations

  • France
    • Var
      • Toulon, Var, France, 83056
        • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patient seen in nurse-led consultations for heart failure between January 1, 2023 and December 31, 2023

Description

Inclusion Criteria:

  • Aged 18 years old or over
  • Patient seen in nurse-led consultations for heart failure between January 1, 2023 and December 31, 2023

Exclusion Criteria:

  • Patient opposition to participate in the study

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
Intervention / Treatment
Patients with chronic heart failure receiving consultations from a Heart Failure Specialist Nurse.
Other: Heart Failure Specialist Nurses consultations
Heart Failure Specialist Nurses consultations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of consultation
Time Frame: 1-year period
Medical telemonitoring, treatment titration, advanced practice nurse follow-up
1-year period
Patient's medical history
Time Frame: 1-year period
Patient's clinical characteristics will be analyzed : number and type of medical histories
1-year period
Treatments implemented
Time Frame: 1-year period
Type and dose of treatment initiated for heart failure will be analyzed.
1-year period
Number of consultations
Time Frame: 1-year period
The number of consultations will be analyzed by type of activity (medical telemonitoring, treatment titration, advanced practice nurse follow-up).
1-year period
Number of hospitalizations
Time Frame: 1-year period
The number of hospitalizations and re-hospitalizations during the 12 months of follow-up will be analyzed.
1-year period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of referral
Time Frame: 1-year period
The type of referral will be analyzed : in-hospital (cardiology or non-cardiology) or out-of-hospital (cardiologist, general practitioner, private nurse or Advanced Practice Registered Nurse)
1-year period
Reason for discontinuation of titration consultation
Time Frame: 1-year period
The reason for the discontinuation of titration consultations will be analyzed.
1-year period
Left ventricular ejection fraction (LVEF)
Time Frame: 1-year period
Echocardiography data during therapy titration will be analyzed.
1-year period
Modification of recommended treatment doses
Time Frame: 1-year period
Modification of recommended treatment doses in heart failure will be analyzed in the overall cohort and according to the level of LVEF at initial management.
1-year period
Rate of detection of iron deficiency
Time Frame: 1-year period
The rate of detection of iron deficiency will be analyzed according to whether or not Ferinject supplementation is used.
1-year period

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

  • Study Director: Mathilde LE CAIGNEC, Nurse, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
  • Study Director: Jocelyne CANDEL, Advanced Practice Nurse, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

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 (Actual)

February 25, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

February 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-CHITS-017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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