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

2026年6月26日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

500

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Montpellier、法国
        • University hospital Montpellier

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
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.
无干预:Control group - Inter-CPTS Aveyron, Creuse and Cantal
Patients aged 60 years and older receiving standard diagnostic care in control rural territories.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Changes in the estimated Annual Incidence of Heart Failure in the geographical area of intervention
大体时间: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
Collected 3 months after the last inclusion.

次要结果测量

结果测量
措施说明
大体时间
Number of Patients whose diagnosis of CI is ruled out (rule-out),
大体时间:3 months after the last inclusion
Number of patients for whom the diagnosis of heart failure is ruled out (rule-out strategy)
3 months after the last inclusion
Number of Hospitalizations or Cardiovascular Events at 1 Year among patients in the experimental group.
大体时间:3 months after the last inclusion
Number of hospitalizations or cardiovascular events occurring within 1 year in the geographical area of the intervention
3 months after the last inclusion
Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Preserved ejection fraction (EF)
大体时间:3 months after the last inclusion
Number of patients classified as having preserved EF after cardiology consultation.
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)
大体时间:3 months after the last inclusion
Number of patients classified as having moderately impaired EF after cardiology consultation.
3 months after the last inclusion
Number of Patient with Heart Failure Classified According to Ejection Fraction After Cardiology Consultation - Impaired ejection fraction (EF)
大体时间:3 months after the last inclusion
Number of patients classified as having impaired EF after cardiology consultation.
3 months after the last inclusion

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Mathilde MINET, MD、University Hospital, Montpellier

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2029年3月1日

研究完成 (估计的)

2029年3月1日

研究注册日期

首次提交

2026年6月26日

首先提交符合 QC 标准的

2026年6月26日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年6月26日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • RECHMPL24_0346
  • 2026-A00369-42 (其他标识符:IdRCB)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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