Screening for Heart Failure in General Medicine Consultations (DEPISTAGE IC)

Screening for Heart Failure in General Medicine Consultations (FIL-EAS ic Depistage)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

216

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

    • Var
      • La Cadière-d'Azur, Var, France, 83740
        • Maison de Santé Pluridisciplinaire La Cadière d'Azur
      • La Farlède, Var, France, 83210
        • Maison de Santé Pluridisciplinaire La Farlède
      • La Seyne-sur-Mer, Var, France, 83500
        • Maison de Santé Pluridisciplinaire Caduceus
      • Le Beausset, Var, France, 83330
        • Maison de Santé Pluridisciplinaire Beaussetanne
      • Solliès-Pont, Var, France, 83210
        • Maison de Santé Pluridisciplinaire Vallée du Gapeau - Sollies-Pont
      • Toulon, Var, France, 83000
        • Maison de Santé Pluridisciplinaire Toulon City

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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 65 years or older participating in the heart failure screening pathway in general medicine consultations

Description

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

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 participating in the heart failure screening pathway in general medicine consultations
Heart failure screening pathway in general medicine consultations (questionnaire, NT-proBNP level, echocardiographic examination)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients with a confirmed diagnosis of heart failure
Time Frame: 2 months
i.e. patients with at least one "yes" box checked in "step 1" and "step 2" of the questionnaire, with an NT-proBNP level ≥ 125 pg/ml, and an echocardiographic examination performed by the cardiologist confirming a diagnosis of HF according to the 2021 ESC guidelines.
2 months
Rate of patients with an unconfirmed diagnosis of heart failure
Time Frame: 2 months

i.e. all of the following patients:

  • Patients with no "yes" boxes checked in steps 1 and 2 of the questionnaire OR one or more "yes" boxes checked but in only one of steps 1 or 2.
  • Patients with at least one "yes" box checked in "step 1" and "step 2" of the questionnaire but with an NT-proBNP level < 125 pg/ml.
2 months
Rate of patients with an indeterminate diagnosis of heart failure
Time Frame: 2 months
Absence of all diagnostic criteria.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors for heart failure
Time Frame: Day 1
Day 1
Presence of dyspnea
Time Frame: Day 1
Evaluation of the main symptoms of heart failure.
Day 1
Weight gain
Time Frame: Day 1
Evaluation of the main symptoms of heart failure.
Day 1
Presence of edema
Time Frame: Day 1
Evaluation of the main symptoms of heart failure.
Day 1
Presence of fatigue
Time Frame: Day 1
Evaluation of the main symptoms of heart failure.
Day 1

Collaborators and Investigators

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

Investigators

  • Study Director: Jean-Michel Tartière, MD, 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)

March 14, 2025

Primary Completion (Actual)

September 15, 2025

Study Completion (Actual)

September 15, 2025

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 7, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-CHITS-003

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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