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临床试验/NCT06865053
NCT06865053已完成不适用

Screening for Heart Failure in General Medicine Consultations (FIL-EAS ic Depistage)

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer7 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2025年3月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
216
试验地点
7
主要终点
Rate of patients with a confirmed diagnosis of heart failure

研究概览

简要总结

Heart failure poses a significant public health challenge due to its high prevalence and the substantial human and financial costs it generates. Furthermore, the lack of clear screening guidelines and challenges in accessing care and multi-professional coordination, contribute to diagnostic delays, leading more patients to seek care in more severe clinical states and requiring direct admission to emergency departments. There is therefore also a major organizational challenge in better managing the entry of patients into the healthcare system. This necessitates the development of structured heart failure screening strategies.

The 2021 European Society of Cardiology (ESC 2021) guidelines on heart failure screening prioritize the identification of at-risk individuals and the early detection of disease manifestations. They suggest that, in high-risk groups, tests such as echocardiography and biomarker measurement (NT-proBNP) should be used to detect heart failure at an early stage, even in the absence of symptoms. The guidelines also delineate specific biomarker thresholds and propose organizational frameworks with defined timelines to facilitate systematic screening.

The implementation of a heart failure screening pathway within primary care involving multi-professional cooperation is therefore warranted.

Stratifying screening based on risk factors and symptomatology is expected to enhance the positive predictive value of the screening process. Furthermore, evaluating the efficacy of this pathway is crucial for establishing a standardized, reproducible clinical protocol suitable for routine primary care practice.

This study is a prospective, multicenter, observational study conducted within the context of routine clinical care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient consulting in general practice.
  • Aged 65 years or older

排除标准

  • Known heart failure.
  • Patient who has already consulted a cardiologist within the last 12 months.
  • Patient opposition to participate in the study

研究组 & 干预措施

Patients participating in the heart failure screening pathway in general medicine consultations

干预措施: Heart failure screening pathway (Other)

结局指标

主要结局

Rate of patients with a confirmed diagnosis of heart failure

时间窗: 2 months

i.e. patients with at least one "yes" box checked in "step 1" and "step 2" of the questionnaire, with an NT-proBNP level ≥ 125 pg/ml, and an echocardiographic examination performed by the cardiologist confirming a diagnosis of HF according to the 2021 ESC guidelines.

Rate of patients with an unconfirmed diagnosis of heart failure

时间窗: 2 months

i.e. all of the following patients: * Patients with no "yes" boxes checked in steps 1 and 2 of the questionnaire OR one or more "yes" boxes checked but in only one of steps 1 or 2. * Patients with at least one "yes" box checked in "step 1" and "step 2" of the questionnaire but with an NT-proBNP level \< 125 pg/ml.

Rate of patients with an indeterminate diagnosis of heart failure

时间窗: 2 months

Absence of all diagnostic criteria.

次要结局

  • Risk factors for heart failure(Day 1)
  • Presence of dyspnea(Day 1)
  • Weight gain(Day 1)
  • Presence of edema(Day 1)
  • Presence of fatigue(Day 1)

研究者

发起方
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
申办方类型
Other
责任方
Sponsor

研究点 (7)

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