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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Experimental group - Inter-CPTS LozèreExperimental treatment 1 intervention
Group B: Control group - Inter-CPTS Aveyron, Creuse and CantalNo intervention 0 interventions

Trial outcomes

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

Time frame
Collected 3 months after the last inclusion.

Secondary outcomes

1

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)

Time frame
3 months after the last inclusion
2

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

Time frame
3 months after the last inclusion
3

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.

Time frame
3 months after the last inclusion
4

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.

Time frame
3 months after the last inclusion

Other outcomes

Sponsors and contacts

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