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NCT Number: NCT07682545

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Montpellier

Montpellier, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Changes in the estimated Annual Incidence of Heart Failure in the geographical area of intervention

    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 :

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

Secondary outcomes

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

    Time frame: 3 months after the last inclusion

    Number of patients for whom the diagnosis of heart failure is ruled out (rule-out strategy)

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

    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

  3. Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Preserved ejection fraction (EF)

    Time frame: 3 months after the last inclusion

    Number of patients classified as having preserved EF after cardiology consultation.

  4. Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Moderately impaired ejection fraction (EF)

    Time frame: 3 months after the last inclusion

    Number of patients classified as having moderately impaired EF after cardiology consultation.

  5. Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Impaired ejection fraction (EF)

    Time frame: 3 months after the last inclusion

    Number of patients classified as having impaired EF after cardiology consultation.

Study contacts

Contact information is provided by the study sponsor or research team.

Mathilde Minet, MD

CONTACT

[email protected]

06 71 11 92 21

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: DIALOZIC

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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