Overview
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.
Description
Heart failure (HF) represents a major health burden in the aging population. Although early identification of HF may provide an opportunity for timely clinical evaluation and management, individuals with early-stage cardiac dysfunction may have no symptoms or only nonspecific symptoms. Screening strategies that rely primarily on symptoms may therefore fail to identify a substantial proportion of older adults with previously unrecognized cardiac dysfunction or HF.
N-terminal pro-B-type natriuretic peptide (NT-proBNP) is an established biomarker associated with cardiac dysfunction and is widely used to support the evaluation of suspected HF. A screening strategy incorporating NT-proBNP may facilitate the identification of older adults who require further cardiac evaluation while reducing the need for universal echocardiographic screening. This study will evaluate whether an NT-proBNP-guided, stepwise screening strategy can improve the detection of previously unrecognized HF in a primary care setting compared with a conventional symptom-based HF screening strategy.
This is a prospective, stratified, cluster-randomized controlled trial. Approximately 2,532 community-dwelling adults aged 65 years or older are planned to be enrolled. Randomization will be conducted at the cluster level, with clusters allocated in a 1:1 ratio to an NT-proBNP-guided screening strategy or a symptom-based HF screening strategy.
In the NT-proBNP-guided HF screening group, NT-proBNP will be measured using residual serum obtained from routine health examinations. Participants with an NT-proBNP level of 125 pg/mL or higher, will be referred for further evaluation, including assessment of HF symptoms, echocardiography, to determine the presence of HF.
In the conventional symptom-based HF screening group, participants with typical symptoms of HF, including dyspnea, chest tightness, fatigue, or lower-extremity edema, will be recommended for further evaluation. These participants will undergo NT-proBNP testing and echocardiography to assess for HF.
After completion of screening, the study will compare the two strategies with respect to the detection rate of newly HF. The study will also compare the HF positive rate and health economic outcomes between the two strategies. Direct and indirect costs associated with the screening pathways will also be collected to support health economic evaluations of the two screening strategies.
The study is designed to determine whether incorporating NT-proBNP into a stepwise HF screening pathway for older adults can improve the identification of previously unrecognized HF compared with a conventional strategy based primarily on clinical symptoms, while also assessing the feasibility and economic implications of implementing such a strategy in primary care.
Eligibility
Inclusion Criteria: 1.Residents aged ≥65 years who are registered as permanent residents of Hushu Town, Jiangning District, Nanjing, China; 2. Have been residing in the local village for an extended period and are enrolled in routine health management services for older adults provided by the local primary healthcare institution; 3. Have normal cognitive function, are capable of independently understanding the study procedures and screening assessments, and voluntarily provide written informed consent.
Exclusion Criteria: 1. An estimated life expectancy of less than 3 months based on a comprehensive assessment by a qualified clinician; 2. A confirmed diagnosis of schizophrenia, severe dementia, or other psychiatric or cognitive disorders that would preclude adequate cooperation with questionnaires, blood sampling, echocardiography, or other study-related screening procedures.
