About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known diagnosis of chronic heart failure (CHF).
Refusal to participate.
Trial population
Adults aged 40 to 80 years with no known history of chronic heart failure (CHF), referred for an outpatient cardiology consultation at participating centers for reasons other than suspected CHF or any of the four EPOF signs. Participants underwent NT-proBNP or BNP measurement as part of routine clinical care, either before or during the cardiology consultation if considered clinically indicated by the treating cardiologist. The study is observational and does not require any additional diagnostic procedures or biomarker testing beyond routine clinical practice.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Sensitivity of the combined EPOF questionnaire and natriuretic peptide strategy for detecting chronic heart failure
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.
Secondary outcomes
Diagnostic performance of the EPOF questionnaire
Diagnostic performance of the EPOF questionnaire and each of its individual components, including sensitivity, specificity, positive predictive value, and negative predictive value with corresponding 95% confidence intervals, 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.
Diagnostic performance of natriuretic peptide measurement
Diagnostic performance of a positive natriuretic peptide result (NT-proBNP ≥125 ng/L or BNP ≥35 ng/L), including sensitivity, specificity, positive predictive value, and negative predictive value with corresponding 95% confidence intervals, 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.
Diagnostic performance of the combined EPOF + NT-proBNP strategy
Diagnostic performance of the combined screening strategy defined as a positive EPOF questionnaire (EPOF score ≥1) and/or a positive NT-proBNP result (≥125 ng/L), including sensitivity, specificity, positive predictive value, and negative predictive value with corresponding 95% confidence intervals, 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.
Diagnostic performance of the combined EPOF + BNP strategy
Diagnostic performance of the combined screening strategy defined as a positive EPOF questionnaire (EPOF score ≥1) and/or a positive BNP result (≥35 ng/L), including sensitivity, specificity, positive predictive value, and negative predictive value with corresponding 95% confidence intervals, 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.
Sponsors and contacts
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