- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07682545
DIALOZIC - Pilot Study of a Diagnostic Pathway for Heart Failure in Rural Areas: the Contribution of Telebiology and Telemedicine (DIALOZIC)
26. juni 2026 oppdatert av: University Hospital, Montpellier
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
500
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mathilde Minet, MD
- Telefonnummer: 06 71 11 92 21
- E-post: mathilde.minet@umontpellier.fr
Studiesteder
-
-
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Montpellier, Frankrike
- University hospital Montpellier
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
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Ingen inngripen: Control group - Inter-CPTS Aveyron, Creuse and Cantal
Patients aged 60 years and older receiving standard diagnostic care in control rural territories.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in the estimated Annual Incidence of Heart Failure in the geographical area of intervention
Tidsramme: Collected 3 months after the last inclusion.
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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 :
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Collected 3 months after the last inclusion.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Patients whose diagnosis of CI is ruled out (rule-out),
Tidsramme: 3 months after the last inclusion
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Number of patients for whom the diagnosis of heart failure is ruled out (rule-out strategy)
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3 months after the last inclusion
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Number of Hospitalizations or Cardiovascular Events at 1 Year among patients in the experimental group.
Tidsramme: 3 months after the last inclusion
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Number of hospitalizations or cardiovascular events occurring within 1 year in the geographical area of the intervention
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3 months after the last inclusion
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Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Preserved ejection fraction (EF)
Tidsramme: 3 months after the last inclusion
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Number of patients classified as having preserved EF after cardiology consultation.
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3 months after the last inclusion
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Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Moderately impaired ejection fraction (EF)
Tidsramme: 3 months after the last inclusion
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Number of patients classified as having moderately impaired EF after cardiology consultation.
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3 months after the last inclusion
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Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Impaired ejection fraction (EF)
Tidsramme: 3 months after the last inclusion
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Number of patients classified as having impaired EF after cardiology consultation.
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3 months after the last inclusion
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Mathilde MINET, MD, University Hospital, Montpellier
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. mars 2029
Studiet fullført (Antatt)
1. mars 2029
Datoer for studieregistrering
Først innsendt
26. juni 2026
Først innsendt som oppfylte QC-kriteriene
26. juni 2026
Først lagt ut (Faktiske)
6. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RECHMPL24_0346
- 2026-A00369-42 (Annen identifikator: IdRCB)
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