This cluster randomized study aims to compare village doctor-led integrated care versus usual care to improve cardiovascular health, atrial fibrillation management, self-management adherence, and heart failure prevention among older rural patients with atrial fibrillation in China.The primary outcome at 12 months is the change in Life's Essential 8 cardiovascular health score from baseline (phase 1). The primary outcome at 36 months is a composite cardiovascular endpoint including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening HF or acute coronary syndrome, and emergency department visits due to AF (phase 2) . The primary outcome at 48 months is new-incident heart-failure diagnosis (phase 3) .An extended observational follow-up, the new-incident heart-failure diagnosis observational follow-up study, will be conducted at Year 7 to evaluate long-term effects.
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A documented history of HF, or newly diagnosed HF according to the 2026 ESC Guidelines for the management of heart failure. HF will require current or prior typical symptoms and/or signs attributable to a structural and/or functional cardiac abnormality. Participants with LVEF <50% will be classified as having heart failure with reduced ejection fraction (HFrEF). In participants with LVEF ≥50%, heart failure with preserved ejection fraction (HFpEF) will require objective evidence of cardiac structural and/or functional abnormalities consistent with left ventricular diastolic dysfunction or elevated filling pressures, supported by elevated natriuretic peptide levels. In participants with AF, supportive echocardiographic abnormalities will include left atrial volume index (LAVI) >40 mL/m², E/e' >15, pulmonary artery systolic pressure >35 mmHg, or tricuspid regurgitation velocity >2.8 m/s.
Expected survival of less than 12 months.
Severe renal insufficiency, defined as creatinine clearance <30 mL/min, or currently receiving dialysis treatment.
Cardiac dysfunction caused by reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
Parallel
Village-Doctor Led Integrated Care
Other intervention1. Village doctor-led management. At least one follow-up contact per month will be completed at the clinic or at home, including symptom assessment, vital-sign monitoring, medication adherence management, cardiovascular risk-factor control and health guidance. 2. Telemedicine specialist support. When symptoms fluctuate, treatment adjustment is difficult or a management problem arises, the village doctor may upload symptoms, ECG recordings, medication information and examination materials through a dedicated telemedicine platform. 3. Standardised guideline training. Village doctors will receive training centred on the AF ABC pathway, covering stroke prevention and anticoagulation, better symptom control, cardiovascular risk-factor management, referral criteria and endpoint identification. 4. Simplified exercise rehabilitation and lifestyle education. Village doctors will deliver enhanced health education in accordance with the study team's 15 core messages for lifestyle-related management
Usual Care
Other interventionParticipants in the control group will receive usual chronic disease management according to the National Basic Public Health Service requirements. Usual care includes routine follow-up, general health education, medication registration, and standard referral procedures provided by local primary care providers. Participants will not receive the structured village-doctor led integrated care program.
Primary Outcome of Phase 1: Change in Life's Essential 8 Cardiovascular Health Score
Mean change in Life's Essential 8 cardiovascular health score from baseline to 12 months. The score includes diet, physical activity, nicotine exposure, sleep health, body mass index, non-HDL cholesterol, blood glucose, and blood pressure.
Primary Outcome of Phase 2: 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.
Primary Outcome of Phase 3: 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.
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.
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 death
Cardiovascular Hospitalization
Hospitalization due to cardiovascular or neurological diseases at township-level or higher hospitals, including heart failure, cardiac arrhythmia, acute coronary syndrome, hypertensive emergency or urgency, ischemic or hemorrhagic stroke, and transient ischemic attack.
Emergency Visit for Cardiovascular Events
Incidence of emergency visits for cardiovascular events, including exacerbation of heart failure or acute coronary syndrome.
ischemic or hemorrhagic Stroke
All strokes: ischemic or hemorrhagic Stroke
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Jiangsu Taizhou People's Hospital
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
