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Набор скоро начнётся NCT07682545

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

Без фазы С лечением Heart Failure Diagnosis Medically Underserved Area

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Point-of-care NT-pro-BNP testing.
Кому может быть актуально
Состояния в реестре: Heart Failure, Diagnosis, Medically Underserved Area. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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.

Первичные конечные точки

  • Changes in the estimated Annual Incidence of Heart Failure in the geographical area of intervention [Срок оценки: Collected 3 months after the last inclusion.]
Вторичные конечные точки (5)
  • Number of Patients whose diagnosis of CI is ruled out (rule-out), [Срок оценки: 3 months after the last inclusion]
  • Number of Hospitalizations or Cardiovascular Events at 1 Year among patients in the experimental group. [Срок оценки: 3 months after the last inclusion]
  • Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Preserved ejection fraction (EF) [Срок оценки: 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) [Срок оценки: 3 months after the last inclusion]
  • Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Impaired ejection fraction (EF) [Срок оценки: 3 months after the last inclusion]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 1 центр
  • University Hospital Montpellier — Montpellier

Идентификаторы

NCT: NCT07682545 · RECHMPL24_0346 · 2026-A00369-42

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗