- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07837349
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. (DECLIC)
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.
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Barnabas GELLEN, MD
- Puhelinnumero: +33 01 44 90 70 28
- Sähköposti: declic@sfcardio.fr
Tutki yhteystietojen varmuuskopiointi
- Nimi: Marc VILLACEQUE, MD
- Puhelinnumero: +33 01 44 90 70 28
- Sähköposti: declic@sfcardio.fr
Opiskelupaikat
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Nîmes, Ranska, 30900
- Private Cardiology Practice
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Ottaa yhteyttä:
- Marc VILLACEQUE, MD
- Puhelinnumero: +33 01 44 90 70 28
- Sähköposti: declic@sfcardio.fr
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Poitiers, Ranska, 86000
- Polyclinique de Poitiers - GCS ELSAN
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Ottaa yhteyttä:
- Barnabas GELLEN, MD
- Puhelinnumero: +33 01 44 90 70 28
- Sähköposti: declic@sfcardio.fr
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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.
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
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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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Sensitivity of the combined EPOF questionnaire and natriuretic peptide strategy for detecting chronic heart failure
Aikaikkuna: Baseline
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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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Diagnostic performance of the EPOF questionnaire
Aikaikkuna: Baseline
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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. |
Baseline
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Diagnostic performance of natriuretic peptide measurement
Aikaikkuna: Baseline
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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. |
Baseline
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Diagnostic performance of the combined EPOF + NT-proBNP strategy
Aikaikkuna: Baseline
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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. |
Baseline
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Diagnostic performance of the combined EPOF + BNP strategy
Aikaikkuna: 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. |
Baseline
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Diagnostic performance in prespecified subgroups
Aikaikkuna: Baseline
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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. |
Baseline
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Prevalence of chronic heart failure
Aikaikkuna: Baseline
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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. |
Baseline
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- 2026-A00207-44
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