Clinical trial NCT06865053: Screening for Heart Failure in General Medicine Consultations
Official title: Screening for Heart Failure in General Medicine Consultations (FIL-EAS ic Depistage)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: heart failure
screening
general medicine
care pathway
Multi-professional cooperation
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
Collaborators: name: Cerballiance
name: Roche Diagnostic Ltd.
First posted: 2025-03-07
Enrollment: 1190
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 65 years or older participating in the heart failure screening pathway in general medicine consultations

Brief summary: Heart failure poses a significant public health challenge due to its high prevalence and the substantial human and financial costs it generates. Furthermore, the lack of clear screening guidelines and challenges in accessing care and multi-professional coordination, contribute to diagnostic delays, leading more patients to seek care in more severe clinical states and requiring direct admission to emergency departments. There is therefore also a major organizational challenge in better managing the entry of patients into the healthcare system. This necessitates the development of structured heart failure screening strategies.

The 2021 European Society of Cardiology (ESC 2021) guidelines on heart failure screening prioritize the identification of at-risk individuals and the early detection of disease manifestations. They suggest that, in high-risk groups, tests such as echocardiography and biomarker measurement (NT-proBNP) should be used to detect heart failure at an early stage, even in the absence of symptoms. The guidelines also delineate specific biomarker thresholds and propose organizational frameworks with defined timelines to facilitate systematic screening.

The implementation of a heart failure screening pathway within primary care involving multi-professional cooperation is therefore warranted.

Stratifying screening based on risk factors and symptomatology is expected to enhance the positive predictive value of the screening process. Furthermore, evaluating the efficacy of this pathway is crucial for establishing a standardized, reproducible clinical protocol suitable for routine primary care practice.

This study is a prospective, multicenter, observational study conducted within the context of routine clinical care.


Eligibility criteria: Inclusion Criteria:

1. Patient consulting in general practice.
2. Aged 65 years or older

Exclusion Criteria:

1. Known heart failure.
2. Patient who has already consulted a cardiologist within the last 12 months.
3. Patient opposition to participate in the study

Primary outcomes:
measure: Rate of patients with a confirmed diagnosis of heart failure
timeFrame: 2 months
measure: Rate of patients with an unconfirmed diagnosis of heart failure
timeFrame: 2 months
measure: Rate of patients with an indeterminate diagnosis of heart failure
timeFrame: 2 months
Secondary outcomes:
measure: Risk factors for heart failure
timeFrame: Day 1
measure: Presence of dyspnea
timeFrame: Day 1
measure: Weight gain
timeFrame: Day 1
measure: Presence of edema
timeFrame: Day 1
measure: Presence of fatigue
timeFrame: Day 1
Other outcomes:
Locations:
city: La Cadière d'Azur
country: France
facility: Maison de Santé Pluridisciplinaire La Cadière d'Azur
state: Var
city: La Farlede
country: France
facility: Maison de Santé Pluridisciplinaire La Farlède
state: Var
city: La Seyne Sur Mer
country: France
facility: Maison de Santé Pluridisciplinaire Caduceus
state: Var
city: Le Beausset
country: France
facility: Maison de Santé Pluridisciplinaire Beaussetanne
state: Var
city: Sollies-pont
country: France
facility: Maison de Santé Pluridisciplinaire Vallée du Gapeau - Sollies-Pont
state: Var
city: Toulon
country: France
facility: Maison de Santé Pluridisciplinaire Toulon City
state: Var
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Jean-Michel TARTIERE, MD
role: STUDY_DIRECTOR
References: