Chronic Heart FailureISPIC FILEASNCT06853353
Nurse-led Consultations in Heart Failure Within the 'FIL-EAS' Evaluation and Support Care Pathway for Heart Failure Patients
An observational study of Chronic Heart Failure, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Heart Failure Specialist Nurses consultations
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2025to 31 Dec 2025
- Phase
- Observational
- 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
Study population: Adult patient seen in nurse-led consultations for heart failure between January 1, 2023 and December 31, 2023
Who may be able to join
- Aged 18 years old or over
- Patient seen in nurse-led consultations for heart failure between January 1, 2023 and December 31, 2023
Who cannot join
- Patient opposition to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83056
About this study
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.
- Conditions
- Chronic Heart Failure
- Being tested
- Heart Failure Specialist Nurses consultations
- Keywords
- Chronic heart failure, Nurse, Heart Failure Nurse Specialists, Advanced practice nursing, Treatment titration, Care pathway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Failure Specialist Nurses consultationsOther
Heart Failure Specialist Nurses consultations
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic heart failure receiving consultations from a Heart Failure Specialist Nurse. | Not described Receives: Other: Heart Failure Specialist Nurses consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of consultation
Medical telemonitoring, treatment titration, advanced practice nurse follow-up
Measured: 1-year period
Patient's medical history
Patient's clinical characteristics will be analyzed : number and type of medical histories
Measured: 1-year period
Treatments implemented
Type and dose of treatment initiated for heart failure will be analyzed.
Measured: 1-year period
Number of consultations
The number of consultations will be analyzed by type of activity (medical telemonitoring, treatment titration, advanced practice nurse follow-up).
Measured: 1-year period
Number of hospitalizations
The number of hospitalizations and re-hospitalizations during the 12 months of follow-up will be analyzed.
Measured: 1-year period
Secondary outcomes (5)
Type of referral
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)
Measured: 1-year period
Reason for discontinuation of titration consultation
The reason for the discontinuation of titration consultations will be analyzed.
Measured: 1-year period
Left ventricular ejection fraction (LVEF)
Echocardiography data during therapy titration will be analyzed.
Measured: 1-year period
Modification of recommended treatment doses
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.
Measured: 1-year period
Rate of detection of iron deficiency
The rate of detection of iron deficiency will be analyzed according to whether or not Ferinject supplementation is used.
Measured: 1-year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start25 Feb 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathilde LE CAIGNEC, Nurse, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur MerJocelyne CANDEL, Advanced Practice Nurse, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853353
- Sponsor's protocol ID
- 2024-CHITS-017
- Acronym
- ISPIC FILEAS
- Status last verified
- Jul 2026
- First submitted
- 25 Feb 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Nurse-led Consultations in Heart Failure Within the 'FIL-EAS' Evaluation and Support Care Pathway for Heart Failure Patients
- ClinicalTrials.gov ID
- NCT06853353
- Acronym / sponsor ID
- ISPIC FILEAS / 2024-CHITS-017
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic heart failure, Nurse, Heart Failure Nurse Specialists, Advanced practice nursing, Treatment titration, Care pathway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 Feb 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic heart failure receiving consultations from a Heart Failure Specialist Nurse. | – | Other: Heart Failure Specialist Nurses consultations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient seen in nurse-led consultations for heart failure between January 1, 2023 and December 31, 2023
Key inclusion criteria (2 listed)
- Aged 18 years old or over
- Patient seen in nurse-led consultations for heart failure between January 1, 2023 and December 31, 2023
Key exclusion criteria (1 listed)
- Patient opposition to participate in the study
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 |
|---|---|---|
| Heart Failure Specialist Nurses consultationsHeart Failure Specialist Nurses consultations | Other | Patients with chronic heart failure receiving consultations from a Heart Failure Specialist Nurse. |
Primary outcome
Type of consultation
Time frame: 1-year period
Medical telemonitoring, treatment titration, advanced practice nurse follow-up
Patient's medical history
Time frame: 1-year period
Patient's clinical characteristics will be analyzed : number and type of medical histories
Treatments implemented
Time frame: 1-year period
Type and dose of treatment initiated for heart failure will be analyzed.
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).
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.
5 secondary outcomes
Type of referral
Time frame: 1-year period
Reason for discontinuation of titration consultation
Time frame: 1-year period
Left ventricular ejection fraction (LVEF)
Time frame: 1-year period
Modification of recommended treatment doses
Time frame: 1-year period
Rate of detection of iron deficiency
Time frame: 1-year period
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.
Related trials for Chronic Heart Failure
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
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.
Mathilde LE CAIGNEC, Nurse study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Jocelyne CANDEL, Advanced Practice Nurse study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site 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 2 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: 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 1 site 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?
Type of consultation (time frame: 1-year period). The study lists 5 primary outcomes in all. 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 7 Jul 2026.