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Life sciences · Interventional Study
ClinicalTrials.gov · October 21, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07885488). This is a study registration, not published results. Lead sponsor: Jiangsu Taizhou People's Hospital. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 2532 participants (ESTIMATED). Conditions: Heart Failure. Interventions: DIAGNOSTIC_TEST: Symptom-based heart failure screening; DIAGNOSTIC_TEST: NT-proBNP-guided heart failure screening. Primary outcome measures: Primary Outcome of Phase 1: New-incident heart-failure diagnosis , 6 months after baseline; Primary Outcome of Extension Study: Composite cardiovascular outcome , 18 months after baseline. Brief summary: Heart failure (HF) is common among older adults and is associated with substantial morbidity, mortality, and healthcare burden. Early stages of HF may be asymptomatic or present with nonspecific symptoms, making early detection challenging when screening relies primarily on clinical symptoms. N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a biomarker that may help identify individuals with previously unrecognized cardiac dysfunction or HF. This study is a prospective, stratified, cluster-randomized controlled trial designed to evaluate an NT-proBNP-driven screening strategy for HF among adults aged 65 years or older in primary care settings. Participating clusters will be randomly assigned in a 1:1 ratio to either an NT-proBNP-guided HF screening strategy or symptom-based HF screening strategy. In the NT-proBNP-guided HF screening group, NT-proBNP will be measured in participants, and those with elevated NT-proBNP levels will be referred for further evaluation, including assessment of HF symptoms, echocardiography, to assess HF. In the symptom-based HF screening group, participants with typical symptoms suggestive of HF will be recommended for further evaluation with NT-proBNP testing and echocardiography for HF. The primary objective is to determine whether an NT-proBNP-guided screening strategy improves the detection rate of newly HF compared with conventional symptom-based HF screening. The study will also compare the HF positive rate and health economic outcomes between the two strategies, as well as adherence to guideline-directed medical therapy among patients with HF.