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Completed

NCT Number: NCT06853353

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83056, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart Failure Specialist Nurses consultations

Other

Heart Failure Specialist Nurses consultations

Primary outcomes

  1. Type of consultation

    Time frame: 1-year period

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

  2. Patient's medical history

    Time frame: 1-year period

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

  3. Treatments implemented

    Time frame: 1-year period

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

  4. 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).

  5. 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.

Secondary outcomes

  1. 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)

  2. Reason for discontinuation of titration consultation

    Time frame: 1-year period

    The reason for the discontinuation of titration consultations will be analyzed.

  3. Left ventricular ejection fraction (LVEF)

    Time frame: 1-year period

    Echocardiography data during therapy titration will be analyzed.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Acronym: ISPIC FILEAS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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