DIALOZIC - Pilot Study of a Diagnostic Pathway for Heart Failure in Rural Areas: the Contribution of Telebiology and Telemedicine

NCT07682545 | Not Yet Recruiting

• 2 other identifiers: RECHMPL24_03462026-A00369-42
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Diagnosis; Medically Underserved Area

Keywords

Heart Failure; NT-proBNP; Telemedicine; Diagnosis; screening; rural area

Outcome Measures

Primary Outcomes (1)

• 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 : * Sacubitril/valsartan and/or * Spironolactone/eplerenone and/or * Glifozine

  Collected 3 months after the last inclusion.

Secondary Outcomes (5)

• Number of Patients whose diagnosis of CI is ruled out (rule-out),

  3 months after the last inclusion

• Number of Hospitalizations or Cardiovascular Events at 1 Year among patients in the experimental group.

  3 months after the last inclusion

• 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 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 Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Impaired ejection fraction (EF)

  3 months after the last inclusion

Study Arms (2)

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.

Diagnostic Test: Point-of-care NT-pro-BNP testing

Control group - Inter-CPTS Aveyron, Creuse and Cantal

NO INTERVENTION

Patients aged 60 years and older receiving standard diagnostic care in control rural territories.

Interventions

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.

Experimental group - Inter-CPTS Lozère

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Heart Failure; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mathilde MINET, MD

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Mathilde Minet, MD

CONTACT

06 71 11 92 21; mathilde.minet@umontpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-06

Locations

FR (1)