An interventional study of Symptom-based heart failure screening and NT-proBNP-guided heart failure screening in Heart Failure, sponsored by Jiangsu Taizhou People's Hospital. Recruiting at 1 site in China. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Jiangsu Taizhou People's Hospital · Not applicable, Interventional, and Screening
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.
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.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's planned enrollment of 2,532 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Jiangsu Taizhou People's Hospital is the lead sponsor of 15 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Participants with typical symptoms of heart failure, including dyspnea, chest tightness, fatigue, or lower-extremity edema, will be recommended for NT-proBNP and echocardiography to further evaluate heart failure.
Diagnostic Test: Symptom-based heart failure screening
Participants with an NT-proBNP level of 125 pg/mL or higher will be recommended to undergo further heart failure symptoms and echocardiographic evaluation for heart failure.
Diagnostic Test: NT-proBNP-guided heart failure screening
Participants with typical symptoms of heart failure, including dyspnea, chest tightness, fatigue or lower-extremity edema, will be recommended for further evaluation with NT-proBNP testing and echocardiography for heart failure.
All participants will undergo NT-proBNP testing. Participants with an NT-proBNP level ≥125 pg/mL will be recommended for heart failure symptoms and echocardiography to identify newly diagnosed heart failure
Primary Outcome of Phase 1: New-incident heart-failure diagnosis
(1) HFrEF - symptomatic cardiac dysfunction with LVEF \< 50%; (2) HFpEF - symptoms of HF with LVEF ≥ 50% and echocardiographic evidence of structural or functional cardiac abnormalities; or (3) hospitalisation with heart failure as a primary cause.
Time frame: 6 months after baseline
Primary Outcome of Extension Study: Composite cardiovascular outcome
Composite cardiovascular endpoint, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure.
Time frame: 18 months after baseline
Positive rate of heart failure
The proportion of participants diagnosed with heart failure among those identified as high-risk by the corresponding screening strategy.
Time frame: 6 months
GDMT medication utilization rate
The proportion of patients who are eligible for guideline-directed medical therapy (GDMT) and actually receive GDMT within 12 Months. Single-class prescription rate: Prescription rate for a given GDMT drug class = (number of patients prescribed that drug class) / (number of patients eligible for that drug class) × 100%. At least one GDMT class prescription rate: At least one GDMT prescription rate = (number of patients prescribed at least one GDMT drug class) / (total number of patients eligible for GDMT) × 100%. Quadruple GDMT prescription rate: Quadruple therapy prescription rate = (number of patients simultaneously prescribed ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) / (number of patients eligible for all four drug classes) × 100%.
Time frame: 6 months
Proportion of participants with newly detected asymptomatic heart failure
The proportion of participants newly diagnosed with asymptomatic heart failure among enrolled elderly participants at 6 months. Heart failure diagnosis will be determined according to the European Society of Cardiology heart failure diagnostic criteria, including heart failure symptoms/signs assessment, echocardiography findings, and elevated natriuretic peptide levels.
Time frame: 6 months
Health economic evaluation
From the perspective of healthcare providers/health system, the study will compare the medical resource utilization and costs related to screening, examinations, referrals, and diagnosis during the implementation of the two HF screening strategies, and evaluate the economic benefits of different screening strategies.
Time frame: 6 months
New-incident heart-failure diagnosis Using different NT-proBNP thresholds
The proportion of participants newly diagnosed with heart failure under different NT-proBNP threshold strategies. Different NT-proBNP cutoff values (e.g., 125 pg/mL, 300 pg/mL, and other predefined thresholds) will be evaluated for their ability to identify newly diagnosed heart failure.
Time frame: 6 months
Plan to share: No
Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
Of 1,018 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 8 months is below that.
Counting every sponsor, half of 1,220 studies reached it within 31 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Jiangsu Taizhou People's Hospital