Evaluation of the Clinical Value of NT-proBNP (or BNP) Measurement, Alone or in Combination With the EPOF Questionnaire, for the Screening of Chronic Heart Failure (CHF) in Adults Aged 40 Years and Older Referred for a Cardiology Consultation Without Suspected CHF.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Sensitivity of the combined EPOF questionnaire and natriuretic peptide strategy for detecting chronic heart failure
研究概览
简要总结
This observational study aims to evaluate whether measuring NT-proBNP (or BNP), either on its own or alongside the EPOF questionnaire, can improve the early detection of chronic heart failure (CHF) in adults aged 40 years or over who are referred for an outpatient cardiology evaluation and have no known or suspected CHF.
The study will address the following questions:
Does systematic NT-proBNP (or BNP) testing help to identify previously unrecognised CHF? Does combining NT-proBNP (or BNP) with the EPOF questionnaire enhance diagnostic accuracy compared with using each tool alone? Participants will attend their routine cardiology consultation, complete the EPOF questionnaire and undergo NT-proBNP (or BNP) testing as part of the clinical assessment. They will also allow the collection of relevant medical data. The diagnostic performance of these tools will then be compared with the final diagnosis made by the outpatient cardiologist.
The study focuses on a population referred from primary care with increased cardiovascular risk. The early use of simple, accessible tools could reduce diagnostic delays, improve referral appropriateness and facilitate the earlier detection of CHF in general practice.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40 to 80 years.
- •Referred for a cardiology consultation for a reason other than suspected chronic heart failure or any of the four EPOF signs.
- •Informed about the study and not objecting to participation, in accordance with applicable regulations.
排除标准
- •Known diagnosis of chronic heart failure (CHF).
- •Refusal to participate.
研究组 & 干预措施
Adults ≥40 years referred for cardiology consultation without suspected chronic heart failure
Adults aged 40 years and older with no history of chronic heart failure (CHF), referred for a cardiology consultation at participating centers for reasons other than suspected CHF, and who underwent NT-proBNP or BNP measurement as part of routine clinical care. The biomarker measurement may have been performed before the consultation or ordered by the treating cardiologist during the consultation if considered clinically indicated, independently of study participation. The study does not require or mandate any additional NT-proBNP or BNP testing; participants are included only if a routine-care biomarker result is available.
结局指标
主要结局
Sensitivity of the combined EPOF questionnaire and natriuretic peptide strategy for detecting chronic heart failure
时间窗: Baseline
Sensitivity (with 95% confidence interval) of the combined screening strategy defined as a positive EPOF questionnaire (EPOF score ≥1) and/or a positive natriuretic peptide result (NT-proBNP ≥125 ng/L or BNP ≥35 ng/L), using the final diagnosis of chronic heart failure established by the treating cardiologist after completion of the routine diagnostic work-up as the reference standard.
次要结局
- Diagnostic performance of the EPOF questionnaire(Baseline)
- Diagnostic performance of natriuretic peptide measurement(Baseline)
- Diagnostic performance of the combined EPOF + NT-proBNP strategy(Baseline)
- Diagnostic performance of the combined EPOF + BNP strategy(Baseline)
- Diagnostic performance in prespecified subgroups(Baseline)
- Prevalence of chronic heart failure(Baseline)