About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Telemedicine-Based Integrated Care Model
- Conventional Management Group