💬In plain words
What the trial is, and whether it could suit you
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 ef
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1\. The village clinics need to be willing and able to provide integrated care to their patients with atrial fibrillation; 2. The village doctors from one village clinic serves all AF patients from 3-5 nearby villages; 3. The village doctors are trained to have a fundamental understanding of telemedicine; 4. Patients are eligible for participation if 1)they aged 65-80 years.
2)Availability of an electrocardiogram confirming atrial fibrillation, or an official diagnosis certificate of atrial fibrillation issued by a specialist.
3)Receiving healthcare management from a primary medical institution near the place of residence.
4)Able to understand and sign the informed consent form.
Exclusion Criteria:
1. 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.
2. Expected survival of less than 12 months.
3. Severe renal insufficiency, defined as creatinine clearance \<30 mL/min, or currently receiving dialysis treatment.
4. Cardiac dysfunction caused by reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
5. Indication for pacemaker implantation but without pacemaker placement.
6. Chronic obstructive pulmonary disease complicated by type II respiratory failure.
7. Special populations, such as patients with mental illness.
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