University Hospital Montpellier
Montpellier, France
NCT Number: NCT07682545
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.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Montpellier, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Collected 3 months after the last inclusion.
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 :
Time frame: 3 months after the last inclusion
Number of patients for whom the diagnosis of heart failure is ruled out (rule-out strategy)
Time frame: 3 months after the last inclusion
Number of hospitalizations or cardiovascular events occurring within 1 year in the geographical area of the intervention
Time frame: 3 months after the last inclusion
Number of patients classified as having preserved EF after cardiology consultation.
Time frame: 3 months after the last inclusion
Number of patients classified as having moderately impaired EF after cardiology consultation.
Time frame: 3 months after the last inclusion
Number of patients classified as having impaired EF after cardiology consultation.
Contact information is provided by the study sponsor or research team.
University Hospital, Montpellier
Other
DIALOZIC - Pilot Study of a Diagnostic Protocol for Heart Failure in Rural Areas: The Role of Telebiology and Telemedicine
Acronym: DIALOZIC
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