- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Barnabas GELLEN, MD
- Número de telefone: +33 01 44 90 70 28
- E-mail: declic@sfcardio.fr
Estude backup de contato
- Nome: Marc VILLACEQUE, MD
- Número de telefone: +33 01 44 90 70 28
- E-mail: declic@sfcardio.fr
Locais de estudo
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Nîmes, França, 30900
- Private Cardiology Practice
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Contato:
- Marc VILLACEQUE, MD
- Número de telefone: +33 01 44 90 70 28
- E-mail: declic@sfcardio.fr
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Poitiers, França, 86000
- Polyclinique de Poitiers - GCS ELSAN
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Contato:
- Barnabas GELLEN, MD
- Número de telefone: +33 01 44 90 70 28
- E-mail: declic@sfcardio.fr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
|---|
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sensitivity of the combined EPOF questionnaire and natriuretic peptide strategy for detecting chronic heart failure
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Diagnostic performance of the EPOF questionnaire
Prazo: 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. |
Baseline
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Diagnostic performance of natriuretic peptide measurement
Prazo: 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. |
Baseline
|
|
Diagnostic performance of the combined EPOF + NT-proBNP strategy
Prazo: 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. |
Baseline
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|
Diagnostic performance of the combined EPOF + BNP strategy
Prazo: 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
Prazo: 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. |
Baseline
|
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Prevalence of chronic heart failure
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 2026-A00207-44
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