An interventional study of Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care Group and Routine Management Group in Atrial Fibrillation (AF) and Heart Failure, sponsored by Jiangsu Taizhou People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Jiangsu Taizhou People's Hospital · Not applicable, Interventional, and Treatment
AF and HF frequently coexist and are associated with poor clinical outcomes. In rural areas, limited access to echocardiography, NT-proBNP testing, and specialist care may hinder the early identification and appropriate management of HF among patients with AF. Mobile clinics may help overcome these barriers by bringing diagnostic testing and specialist support directly to rural communities.
This cluster-randomized controlled trial aims to evaluate a mobile clinic-supported, village doctor-led model for HF screening and integrated management among older patients with AF in rural China. Mobile clinics equipped with echocardiography and NT-proBNP testing will support HF screening, and subsequent management will be tailored according to HF status. The study will evaluate whether this model can improve the detection of HF and reduce adverse cardiovascular events compared with routine management.
AF and HF frequently coexist and are associated with poor clinical outcomes. In rural areas, limited access to echocardiography, NT-proBNP testing, and specialist care may hinder the early identification and appropriate management of HF among patients with AF. Mobile clinics may help overcome these barriers by bringing diagnostic testing and specialist support directly to rural communities.
This is an open-label, cluster-randomized, parallel-group controlled trial conducted in rural village clinics in Donghai County, Jiangsu Province, China. Village clinics will be randomized in a 1:1 ratio to either a mobile clinic-supported, village doctor-led integrated management group or a routine management group.
In the intervention group, mobile clinics equipped with echocardiography and NT-proBNP testing will provide HF screening. Based on HF status, village doctors and specialists will provide stratified management, including AF management based on the ABC pathway and optimization of guideline-directed medical therapy for HF when appropriate. The control group will receive routine management according to the National Basic Public Health Service standards.
The study will evaluate the rate of newly detected HF at 6 months and a composite cardiovascular outcome at 18 months, including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening HF or acute coronary syndrome, and AF-related emergency department visits.
3,958 studies on the registry are indexed under Atrial Fibrillation; 934 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 145 across 2,438 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Jiangsu Taizhou People's Hospital is the lead sponsor of 16 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Participants in this group will receive mobile clinic-supported, village doctor-led integrated management. Mobile clinics equipped with echocardiography and NT-proBNP testing will provide HF screening for patients with AF. Based on HF status, village doctors and specialists will provide stratified management, including AF management according to the ABC pathway and optimization of guideline-directed medical therapy for HF when appropriate. Specialist-supported mobile clinics will provide regular assessment and medication adjustment (once every 3 months), while village doctors will conduct ongoing follow-up and health management.
Behavioral: Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care Group
Participants in this group will receive routine chronic disease management according to the National Basic Public Health Service standards. Village doctors will provide regular follow-up, general health education, medication documentation, and routine referral services. Participants will not receive mobile clinic-supported HF screening or the structured guideline-based management provided to the intervention group.
Behavioral: Routine Management Group
The intervention consists of mobile clinic-supported HF screening and village doctor-led integrated management for patients with AF. Mobile clinics equipped with echocardiography and NT-proBNP testing will provide HF screening. Management will be stratified according to HF status. Patients without HF will receive integrated AF management based on the ABC pathway, while patients with HF will additionally receive guideline-directed HF management, including optimization of GDMT. Specialists will conduct regular assessments and medication adjustments (once every 3 months), and village doctors will provide ongoing follow-up, medication review, risk-factor management, and health guidance.
Participants in the control group will receive routine chronic disease management according to the National Basic Public Health Service standards. Village doctors will provide regular follow-up, general health education, medication documentation, and routine referral services. Participants will continue to receive clinically indicated care but will not receive the mobile clinic-supported HF screening or structured guideline-based management provided to the intervention group.
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 Phase 2: Composite Cardiovascular Outcome
The composite outcome includes cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening heart failure or acute coronary syndrome, and emergency department visits due to atrial fibrillation.
Time frame: 18 months after baseline
Primary Outcome of Extension Study: Composite cardiovascular outcome
Composite cardiovascular endpoint, including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening heart failure or acute coronary syndrome, and emergency visits due to atrial fibrillation.
Time frame: 36 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway adherence
Proportion of participants meeting all three ABC criteria. 'A' (avoid stroke): appropriate oral anticoagulation according to guideline indications, defined as use of an appropriately dosed direct oral anticoagulant or warfarin with time in therapeutic range \>65%.Patients who were not properly treated with OACs are considered as 'A non-compliant'. 'B' (Better functional status): Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. 'C' (comorbidity and cardiovascular risk-factor management): 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'.
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. 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
Incidence and Time to Cardiovascular Death
Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular deathTime
Time frame: 18 months
Incidence and Time to Ischemic or Hemorrhagic Stroke
All strokes: ischemic or hemorrhagic Stroke
Time frame: 18 months
Incidence and Time to Hospitalization for Worsening Heart Failure or Acute Coronary Syndrome
Hospitalization due to worsening heart failure or acute coronary syndrome during follow-up.
Time frame: 18 months
Incidence and Time to Emergency visit due to Atrial Fibrillation
Occurrence of an emergency department visit due to atrial fibrillation during follow-up
Time frame: 18 months
All-Cause Mortality
Death from any cause during the follow-up period.
Time frame: 18 months
The proportion of patients who met all the three criteria for the ABC pathway adherence
Proportion of participants meeting all three ABC criteria. 'A' (avoid stroke): appropriate oral anticoagulation according to guideline indications, defined as use of an appropriately dosed direct oral anticoagulant or warfarin with time in therapeutic range \>65%.Patients who were not properly treated with OACs are considered as 'A non-compliant'. 'B' (Better functional status): Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. 'C' (comorbidity and cardiovascular risk-factor management): 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'.
Time frame: 18 months
GDMT medication utilization rate
The proportion of patients who are eligible for guideline-directed medical therapy (GDMT) and actually receive GDMT. 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: 18 months
Plan to share: No
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Jiangsu Taizhou People's Hospital