Village doctor–led telehealth care to prevent heart failure in AF patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cluster randomized study compares a village doctor–led integrated care model delivered via telemedicine with standard care for older rural AF patients in China. The program emphasizes regular follow-up, medication review, cardiovascular risk monitoring, ABC pathway–based AF management, and simplified exercise rehabilitation. Primary outcomes are 12-month changes in Life’s Essential 8 cardiovascular health score (phase 1), a composite cardiovascular endpoint at 36 months (phase 2), and new-incident heart failure at 48 months (phase 3), with an observational follow-up at year 7. The trial addresses access gaps in rural primary care by leveraging village doctors and telemedicine to improve AF management and HF prevention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Village Clinics in Dongtai City, Jiangsu Province
  Yancheng, Dongtai, China Recruiting
• Village Clinics in Jiangdu District, Jiangsu Province
  Yangzhou, Jiangdu, China Recruiting
• Village Clinics in Suining County, Jiangsu Province
  Xuzhou, Suining, China Recruiting

Study contacts

• Study coordinator: Ming Chu
• Email: chuming@njmu.edu.cn
• Phone: 13814010410

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.