NCT06853353

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

February 25, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

February 25, 2025

Last Update Submit

April 10, 2026

Conditions

Chronic Heart Failure

Keywords

Chronic heart failureNurseHeart Failure Nurse SpecialistsAdvanced practice nursingTreatment titrationCare pathway

Outcome Measures

Primary Outcomes (5)

  • Type of consultation

    Medical telemonitoring, treatment titration, advanced practice nurse follow-up

    1-year period

  • Patient's medical history

    Patient's clinical characteristics will be analyzed : number and type of medical histories

    1-year period

  • Treatments implemented

    Type and dose of treatment initiated for heart failure will be analyzed.

    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).

    1-year period

  • Number of hospitalizations

    The number of hospitalizations and re-hospitalizations during the 12 months of follow-up will be analyzed.

    1-year period

Secondary Outcomes (5)

  • Type of referral

    1-year period

  • Reason for discontinuation of titration consultation

    1-year period

  • Left ventricular ejection fraction (LVEF)

    1-year period

  • Modification of recommended treatment doses

    1-year period

  • Rate of detection of iron deficiency

    1-year period

Study Arms (1)

Patients with chronic heart failure receiving consultations from a Heart Failure Specialist Nurse.

Other: Heart Failure Specialist Nurses consultations

Interventions

Heart Failure Specialist Nurses consultationsOTHER

Heart Failure Specialist Nurses consultations

Patients with chronic heart failure receiving consultations from a Heart Failure Specialist Nurse.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patient opposition to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83056, France

Location

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2025

First Posted

February 28, 2025

Study Start

February 25, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

FR(1)