Population-based Atrial Fibrillation Screening in Individuals With NT-proBNP Above Median in the Tromsø Study
NCT07343895
Arrhythmias, Cardiac, Atrial Fibrillation
Tromsø, Norway
View Trial DetailsNCT Number: NCT07837349
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.
Trial opening soon.
Get Notified40 year–80 year
All sexes
Observational
Private Cardiology Practice, Nîmes, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Barnabas GELLEN, MD
CONTACT
01 44 90 70 28 ext. +33
Marc VILLACEQUE, MD
CONTACT
01 44 90 70 28 ext. +33
French Cardiology Society
Other
Acronym: DECLIC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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