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

DIALOZIC - Pilot Study of a Diagnostic Protocol for Heart Failure in Rural Areas: The Role of Telebiology and Telemedicine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Diagnosis; Medically Underserved Area
• Intervention / Treatment: Diagnostic test: Point-of-care NT-pro-BNP testing

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathilde Minet, MD; Phone Number: 06 71 11 92 21; Email: mathilde.minet@umontpellier.fr

Study Locations

• France
  • Montpellier, France
    • University Hospital Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group - Inter-CPTS Lozère; 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; 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.
No Intervention: Control group - Inter-CPTS Aveyron, Creuse and Cantal; Patients aged 60 years and older receiving standard diagnostic care in control rural territories.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 : Sacubitril/valsartan and/or; Spironolactone/eplerenone and/or; Glifozine	Collected 3 months after the last inclusion.

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Mathilde MINET, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure; Telemedicine; Diagnosis; screening; NT-proBNP; rural area
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Heart Failure; Disease
• Other Study ID Numbers: RECHMPL24_0346; 2026-A00369-42 (Other Identifier: IdRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No