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

• 1 other identifier: 2026-A00207-44
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

NT-proBNP; CHF; Chronic Heart Failure

Keywords

NT-proBNP; CHF; Chronic Heart Failure; Natriuretic Peptide Testing; BNP; Cardiology Consultation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (6)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• French Cardiology Society: lead

Study Sites (2)

Private Cardiology Practice

Nîmes, 30900, France

Location

Polyclinique de Poitiers - GCS ELSAN

Poitiers, 86000, France

Location

Central Study Contacts

Barnabas GELLEN, MD

CONTACT

01 44 90 70 28; declic@sfcardio.fr

Marc VILLACEQUE, MD

CONTACT

01 44 90 70 28; declic@sfcardio.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: September 23, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

FR (2)