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OpenTrials
Completed

NCT Number: NCT06865053

Screening for Heart Failure in General Medicine Consultations

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maison de Santé Pluridisciplinaire La Cadière d'Azur, La Cadière-d'Azur, Var, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient consulting in general practice.
  • Aged 65 years or older

Exclusion criteria

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

Treatment and study plan

Heart failure screening pathway

Other

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

Primary outcomes

  1. 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. 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.
  3. Rate of patients with an indeterminate diagnosis of heart failure

    Time frame: 2 months

    Absence of all diagnostic criteria.

Secondary outcomes

  1. Risk factors for heart failure

    Time frame: Day 1

  2. Presence of dyspnea

    Time frame: Day 1

    Evaluation of the main symptoms of heart failure.

  3. Weight gain

    Time frame: Day 1

    Evaluation of the main symptoms of heart failure.

  4. Presence of edema

    Time frame: Day 1

    Evaluation of the main symptoms of heart failure.

  5. Presence of fatigue

    Time frame: Day 1

    Evaluation of the main symptoms of heart failure.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Collaborators

  • Cerballiance
  • Roche Diagnostic Ltd.

Registry information

Official study title

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

Acronym: DEPISTAGE IC

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 7, 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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