- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07682545
DIALOZIC - Pilot Study of a Diagnostic Pathway for Heart Failure in Rural Areas: the Contribution of Telebiology and Telemedicine (DIALOZIC)
26 juni 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
500
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Mathilde Minet, MD
- Telefonnummer: 06 71 11 92 21
- E-post: mathilde.minet@umontpellier.fr
Studieorter
-
-
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Montpellier, Frankrike
- University hospital Montpellier
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes in the estimated Annual Incidence of Heart Failure in the geographical area of intervention
Tidsram: 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 :
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Collected 3 months after the last inclusion.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Patients whose diagnosis of CI is ruled out (rule-out),
Tidsram: 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.
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Mathilde MINET, MD, University Hospital, Montpellier
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 mars 2029
Avslutad studie (Beräknad)
1 mars 2029
Studieregistreringsdatum
Först inskickad
26 juni 2026
Först inskickad som uppfyllde QC-kriterierna
26 juni 2026
Första postat (Faktisk)
6 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RECHMPL24_0346
- 2026-A00369-42 (Annan identifierare: IdRCB)
Plan för individuella deltagardata (IPD)
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