The purpose of this study is to prevent heart failure in older adults (aged 65-80 years) living in rural China who have atrial fibrillation but do not currently have heart failure. Because atrial fibrillation significantly increases the risk of developing heart failure , this cluster-randomized trial tests whether a telemedicine-supported, village doctor-led integrated care model can improve long-term cardiovascular health compared to standard care. Participants are assigned by their local village clinic to receive either conventional routine medical care or a digital-smart management program. The integrated program includes using wearable devices to monitor daily health, participating in structured lifestyle improvement programs focusing on exercise, diet, smoking cessation, and sleep, and receiving optimized medication plans supported by remote cardiovascular specialists. Researchers will measure overall improvements in cardiovascular health using the Life's Essential 8 score at 12 months, track major cardiovascular events like heart failure hospitalizations or stroke at 36 months, and evaluate the development of asymptomatic heart dysfunction at 48 months.
Permanent residents with household registration in primary care jurisdictions of Jiangsu Province, aged 65 to 80 years;
Availability of an electrocardiogram confirming atrial fibrillation, or an official diagnosis certificate of atrial fibrillation issued by a specialist;
Receiving healthcare management from the primary medical institution nearest to the place of residence;
Capable of understanding and signing the informed consent form.
A definite history of heart failure, or a confirmed diagnosis of cardiac dysfunction via echocardiography and/or NT-proBNP screening. Diagnostic criteria: Presence of typical heart failure symptoms/signs, accompanied by either reduced left ventricular ejection fraction (HFrEF, LVEF < 40%), mildly reduced left ventricular ejection fraction (HFmrEF, LVEF 40-49%), or preserved left ventricular ejection fraction with elevated NT-proBNP and structural heart disease changes (HFpEF, LVEF ≥ 50%);
Expected survival of less than 3 months;
Patients with severe renal insufficiency (Ccr < 30 mL/min) or those undergoing dialysis treatment;
Cardiac dysfunction caused by various reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, and uncorrected congenital heart disease;
Parallel
Telemedicine-Based Integrated Care Model
Other interventionThis intervention is a village doctor-led, telemedicine-supported integrated care model. It utilizes an Internet of Things (IoT)-enabled digital health platform that automatically collects data from clinic devices and patient wearables (HUAWEI Band 6). The platform provides primary care doctors with clinical decision support for Guideline-Directed Medical Therapy (GDMT) and the atrial fibrillation ABC pathway, facilitating remote tele-consultations with cardiovascular specialists when clinical targets are not met. Furthermore, it includes a structured lifestyle intervention featuring monthly peer-support cardiac rehabilitation sessions at township health centers, along with automated, personalized behavioral education based on quarterly assessments
Conventional Management Group
Other interventionParticipants in the conventional management group receive standard medical care and routine Basic Public Health Services (BPHS) provided by primary care physicians at their local village clinics. This includes standard quarterly follow-up visits for common chronic disease management, an annual free physical examination, and the distribution of general health education materials. Unlike the intervention arm, these participants do not use the IoT-enabled digital health platform, wearable monitoring devices, or participate in the structured multidimensional lifestyle intervention program.
Mean Change from Baseline in the Overall Life's Essential 8 (LE8) Score
The LE8 score aggregates metrics across two domains: health behaviors (diet, physical activity, nicotine exposure, and sleep health) and health factors (body mass index, non-HDL cholesterol, blood glucose, and blood pressure). Each of the 8 metrics is scored on a scale of 0 to 100. To resolve multiple assessments into a single reported value, the overall LE8 score is calculated as the unweighted arithmetic mean of these 8 components. This calculation yields a single composite score ranging from 0 to 100, where higher scores indicate better cardiovascular health (High: 80-100; Moderate: 50-79; Low: 0-49). This outcome evaluates the mean change in this single aggregated score from baseline.
Number of Participants Experiencing a Composite Cardiovascular Endpoint Event
This outcome reports the total number of participants who experience at least one of the protocol-defined cardiovascular events. To arrive at a single reported value, the following specific clinical events are aggregated into one composite endpoint: cardiovascular death, ischemic or hemorrhagic stroke, hospitalization due to worsening heart failure (HF) or acute coronary syndrome (ACS), and emergency visits due to atrial fibrillation.
Number of Participants with Incident Asymptomatic Left Ventricular Dysfunction or Heart Failure
This outcome measures the total number of participants who develop incident asymptomatic left ventricular dysfunction with or without heart failure.
Number of Participants Experiencing Cardiovascular Death
This outcome reports the total number of participants who die from cardiovascular causes. This includes death due to acute myocardial infarction, heart failure, cardiac arrhythmia, cardiac perforation, cardiac tamponade, or other cardiogenic causes, as well as deaths caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism.
Number of Participants Requiring Hospitalization for Cardiovascular or Neurological Events
This outcome measures the number of participants requiring hospitalization in township-level or higher hospitals caused by cardiovascular diseases (such as sudden cardiac death, heart failure, cardiac arrhythmia, acute coronary syndrome, hypertensive emergency) or neurological diseases (ischemic or hemorrhagic stroke, transient ischemic attack).
Number of Participants with Emergency Visits for Cardiovascular Events
This outcome reports the number of participants requiring emergency medical visits due to the exacerbation of heart failure or acute coronary syndrome.
Number of Participants Experiencing a Stroke
This outcome tracks the number of participants with a new onset of neurological deficit symptoms or signs lasting at least 24 hours, categorized as either ischemic or hemorrhagic stroke confirmed by cranial CT/MRI or a neurological expert group.
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