Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2026-A00369-42 | Other Identifier | IdRCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Heart failure is under-diagnosed, even though it is a highly prevalent pathology. The difficulties are accentuated in areas with low medical density. The aim of this project is to demonstrate the value, in terms of diagnosing heart failure, of a Nt-Pro-BNP point of care Test (POCT)in general practices. The aim of this pilot study is to evaluate the reliability of a diagnosis pathway adapted to a low medical density region.
Heart failure is a frequent pathology, under-diagnosed specially in elderly patients due to sometimes non-specific clinical signs. Diagnosis requires coordination between primary care, biology platforms and cardiology teams for cross-disciplinary management. This is not easy to achieve in areas with a low medical density, and the challenge is to propose care pathways adapted to the region, to avoid patients losing out in these Brefterritoires. This multicentric study, using a "here/elsewhere" and "before/after" format, will examine the benefits of capillary NT-pro-BNP POCT directly available by the general practitioner on the basis of warning signs. A coordinated care pathway is set up with local resources. If the Nt-pro-BNP is above the age adapted exclusion cut-off value, the patient receives multi-professional support for the diagnosis and follow-up of diagnosed heart failure via local cardiologists. If an appointements with a cardiologist could not be obtained within 3 months, a fast-echo will be performed by a clinician trained in ultrasound methods. The fast echo, ECG and clinical data will be analyzed using teleexpertise support by a cardiologist of the Montpellier University Hospital. The patient follow-up will be performed by the general practician. A final evaluation will be performed at 1 year.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group - Inter-CPTS Lozère | Experimental | Patients aged 60 years and older presenting at least one EPOF sign suggestive of heart failure (Essoufflement, Prise de poids, Œdèmes, Fatigue; corresponding to shortness of breath, weight gain, edema, and fatigue) and managed through a diagnostic pathway including point-of-care NT-pro-BNP testing and cardiology assessment. |
|
| Control group - Inter-CPTS Aveyron, Creuse and Cantal | No Intervention | Patients aged 60 years and older receiving standard diagnostic care in control rural territories. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-care NT-pro-BNP testing | Diagnostic Test | Capillary NT-pro-BNP testing performed in primary care settings using a point-of-care platform to support early diagnosis of heart failure in rural territories. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the estimated Annual Incidence of Heart Failure in the geographical area of intervention | The primary outcome is changes in the estimated annual incidence of heart failure in the geographical area of intervention using data from French National Health Data System (SNDS). Incidental cases are defined as subject with first dispensing of at least one of the following :
| Collected 3 months after the last inclusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients whose diagnosis of CI is ruled out (rule-out), | Number of patients for whom the diagnosis of heart failure is ruled out (rule-out strategy) | 3 months after the last inclusion |
| Number of Hospitalizations or Cardiovascular Events at 1 Year among patients in the experimental group. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathilde Minet, MD | Contact | 06 71 11 92 21 | mathilde.minet@umontpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mathilde MINET, MD | University Hospital, Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Montpellier | Montpellier | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multicenter category 2 interventional study using a before/after and here/elsewhere design. The intervention group includes 3 primary care territorial communities (CPTS) in Lozère, while the control group includes inter-CPTS from demographically similar rural departments (Aveyron, Creuse, and Cantal).
Not provided
Not provided
Not provided
Not provided
Number of hospitalizations or cardiovascular events occurring within 1 year in the geographical area of the intervention |
| 3 months after the last inclusion |
| Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Preserved ejection fraction (EF) | Number of patients classified as having preserved EF after cardiology consultation. | 3 months after the last inclusion |
| Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Moderately impaired ejection fraction (EF) | Number of patients classified as having moderately impaired EF after cardiology consultation. | 3 months after the last inclusion |
| Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Impaired ejection fraction (EF) | Number of patients classified as having impaired EF after cardiology consultation. | 3 months after the last inclusion |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004194 | Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided