Heart FailureNCT07885488
Screening Elderly Adults in Rural Communities for Heart Failure Using an NT-proBNP-Guided Strategy in China (SEARCH-HF)
A study testing Symptom-based heart failure screening and NT-proBNP-guided heart failure screening in people with Heart Failure, run by Jiangsu Taizhou People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Symptom-based heart failure screening and NT-proBNP-guided heart failure screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,532 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hushu Community Health Service Center
Nanjing
Li Wang, BMed, +86 13913398668, 826114328@qq.com
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Heart Failure
- Being tested
- Symptom-based heart failure screening, NT-proBNP-guided heart failure screening
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom-based heart failure screeningDiagnostic test
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.
NT-proBNP-guided heart failure screeningDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Symptom-based heart failure screening | Active comparator | 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. Receives: Diagnostic Test: Symptom-based heart failure screening |
| NT-proBNP-guided heart failure screening | Experimental | 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. Receives: Diagnostic Test: NT-proBNP-guided heart failure screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months after baseline
Secondary outcomes (5)
Positive rate of heart failure
The proportion of participants diagnosed with heart failure among those identified as high-risk by the corresponding screening strategy.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,532 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Taizhou People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885488
- Sponsor's protocol ID
- LSKY 2026-137-01
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39287754Saito 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.
PubMed 40187528Wang 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.
PubMed 34455858
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Elderly Adults in Rural Communities for Heart Failure Using an NT-proBNP-Guided Strategy in China (SEARCH-HF)
- ClinicalTrials.gov ID
- NCT07885488
- Acronym / sponsor ID
- LSKY 2026-137-01
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,532 participants (estimated)
- Lead sponsor
- Jiangsu Taizhou People's HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptom-based heart failure screening | Active comparator | Diagnostic Test: Symptom-based heart failure screeningParticipants 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 | Experimental | Diagnostic Test: NT-proBNP-guided heart failure screeningParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom-based heart failure screeningParticipants 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. | Diagnostic test | Symptom-based heart failure screening |
| NT-proBNP-guided heart failure screeningAll 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 | Diagnostic test | NT-proBNP-guided heart failure screening |
Primary outcome
Primary Outcome of Phase 1: New-incident heart-failure diagnosis
Time frame: 6 months after baseline
(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.
Primary Outcome of Extension Study: Composite cardiovascular outcome
Time frame: 18 months after baseline
Composite cardiovascular endpoint, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure.
5 secondary outcomes
Positive rate of heart failure
Time frame: 6 months
GDMT medication utilization rate
Time frame: 6 months
Proportion of participants with newly detected asymptomatic heart failure
Time frame: 6 months
Health economic evaluation
Time frame: 6 months
New-incident heart-failure diagnosis Using different NT-proBNP thresholds
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 39287754Kosyakovsky 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.
- Background: PubMed 40187528Saito 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.
- Background: PubMed 34455858Wang 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.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom-based heart failure screening and NT-proBNP-guided heart failure screening in people with Heart Failure, run by Jiangsu Taizhou People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Chu, Dr. (+86 13814010410, chuming@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome of Phase 1: New-incident heart-failure diagnosis (time frame: 6 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07885488, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.