Screening Elderly Adults in Rural Communities for Heart Failure Using an NT-proBNP-Guided Strategy in China (SEARCH-HF)
1 other identifier
interventional
2,532
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Oct 2026
Shorter than P25 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2026
CompletedFirst Submitted
Initial submission to the registry
October 3, 2026
CompletedFirst Posted
Study publicly available on registry
October 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
October 21, 2026
October 1, 2026
9 months
October 3, 2026
October 20, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
18 months after baseline
Secondary Outcomes (5)
Positive rate of heart failure
6 months
GDMT medication utilization rate
6 months
Proportion of participants with newly detected asymptomatic heart failure
6 months
Health economic evaluation
6 months
New-incident heart-failure diagnosis Using different NT-proBNP thresholds
6 months
Study Arms (2)
Symptom-based heart failure screening
ACTIVE COMPARATORParticipants 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.
NT-proBNP-guided heart failure screening
EXPERIMENTALParticipants 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.
Interventions
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
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hushu Community Health Service Center
Nanjing, China
Related Publications (3)
Kosyakovsky LB, de Boer RA, Ho JE. Screening for Heart Failure: Biomarkers to Detect Heightened Risk in the General Population. Curr Heart Fail Rep. 2024 Dec;21(6):591-603. doi: 10.1007/s11897-024-00686-6. Epub 2024 Sep 17.
PMID: 39287754BACKGROUNDSaito Y, Kagiyama N, Harada T, Kaneko T, Kagami K, Dotare T, Yuasa N, Sato E, Sorimachi H, Murata A, Kawagoshi M, Nishiya Y, Yasui A, Okumura Y, Minamino T, Ishii H, Obokata M. An evidence-based tool for screening for heart failure with preserved ejection fraction in primary care: The BREATH2 score. J Cardiol. 2025 Sep;86(3):264-271. doi: 10.1016/j.jjcc.2025.03.018. Epub 2025 Apr 3.
PMID: 40187528BACKGROUNDWang H, Chai K, Du M, Wang S, Cai JP, Li Y, Zeng P, Zhu W, Zhan S, Yang J. Prevalence and Incidence of Heart Failure Among Urban Patients in China: A National Population-Based Analysis. Circ Heart Fail. 2021 Oct;14(10):e008406. doi: 10.1161/CIRCHEARTFAILURE.121.008406. Epub 2021 Aug 28.
PMID: 34455858BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2026
First Posted
October 21, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
October 21, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will not share