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.

NCT07837349 — Not yet recruiting, 1000 participants, French Cardiology Society

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Registry	NCT07837349, acronym DECLIC
Status	Not yet recruiting
Study type	Observational
Enrollment	1000 (Estimated)
Sponsor	French Cardiology Society (Other)
Conditions	NT-pro-BNP, NT-proBNP, CHF, Chronic Heart Failure
Dates	start 2026-09-01 (estimated), primary completion 2027-04-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-09-23, last updated 2026-09-23
Locations	2 sites in France

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
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.

+Outcome measures

Primary outcomes

Sensitivity of the combined EPOF questionnaire and natriuretic peptide strategy for detecting chronic heart failure [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.

Secondary outcomes

Diagnostic performance of the EPOF questionnaire [Baseline]: 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 [Baseline]: 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 [Baseline]: 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 [Baseline]: 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.
Diagnostic performance in prespecified subgroups [Baseline]: Diagnostic performance of the EPOF questionnaire, natriuretic peptide measurement, and the combined screening strategies in prespecified exploratory subgroups defined by sex (men and women), age (40-59 years and ≥60 years), and body mass index (<30 kg/m² and ≥30 kg/m²). Diagnostic performance measures include sensitivity, specificity, positive predictive value, and negative predictive value with corresponding 95% confidence intervals.
Prevalence of chronic heart failure [Baseline]: Prevalence of chronic heart failure, defined as the proportion of participants with a final diagnosis of chronic heart failure established by the treating cardiologist after completion of the routine diagnostic work-up, reported with the corresponding 95% confidence interval.

+Eligibility

Sex: All, ages: 40 Years to 80 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Known diagnosis of chronic heart failure (CHF).
* Refusal to participate.

+Locations (2)

Facility	City	Country	Status
Private Cardiology Practice	Nîmes	France
Polyclinique de Poitiers - GCS ELSAN	Poitiers	France