- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06865053
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Var
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La Cadière-d'Azur, Var, France, 83740
- Maison de Santé Pluridisciplinaire La Cadière d'Azur
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La Farlède, Var, France, 83210
- Maison de Santé Pluridisciplinaire La Farlède
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La Seyne-sur-Mer, Var, France, 83500
- Maison de Santé Pluridisciplinaire Caduceus
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Le Beausset, Var, France, 83330
- Maison de Santé Pluridisciplinaire Beaussetanne
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Solliès-Pont, Var, France, 83210
- Maison de Santé Pluridisciplinaire Vallée du Gapeau - Sollies-Pont
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Toulon, Var, France, 83000
- Maison de Santé Pluridisciplinaire Toulon City
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
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:
|
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
Investigators
- Study Director: Jean-Michel Tartière, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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