Diagnosis, Heart Failure, Medically Underserved Area
Conditions
Keywords
Heart Failure, NT-proBNP, Telemedicine, Diagnosis, screening, rural area
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTPoint-of-care NT-pro-BNP testing
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.
Sponsors
University Hospital, Montpellier
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 60 years of age * Patient presenting at least 1 sign of EPOF on clinical examination (Shortness of breath at rest or on exertion, orthopnea, nocturnal cough; Rapid weight gain, hepatomegaly ; Peripheral edema ; Fatigue (asthenia), difficulty performing daily activities)
Exclusion criteria
* Patients covered by Articles L1121-5 through L1121-8 of the Public Health Code (persons under legal protection, guardianship, or conservatorship) * Patients not enrolled in the French social security system or an equivalent program * Lack of free and informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the estimated Annual Incidence of Heart Failure in the geographical area of intervention | 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 : * Sacubitril/valsartan and/or * Spironolactone/eplerenone and/or * Glifozine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients whose diagnosis of CI is ruled out (rule-out), | 3 months after the last inclusion | Number of patients for whom the diagnosis of heart failure is ruled out (rule-out strategy) |
| Number of Hospitalizations or Cardiovascular Events at 1 Year among patients in the experimental group. | 3 months after the last inclusion | Number of hospitalizations or cardiovascular events occurring within 1 year in the geographical area of the intervention |
| Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Preserved ejection fraction (EF) | 3 months after the last inclusion | Number of patients classified as having preserved EF after cardiology consultation. |
| Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Moderately impaired ejection fraction (EF) | 3 months after the last inclusion | Number of patients classified as having moderately impaired EF after cardiology consultation. |
| Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Impaired ejection fraction (EF) | 3 months after the last inclusion | Number of patients classified as having impaired EF after cardiology consultation. |
Countries
France
Contacts
CONTACTMathilde Minet, MD
STUDY_DIRECTORMathilde MINET, MD
University Hospital, Montpellier
Outcome results
None listed