Village doctor care to prevent heart failure in older rural people with atrial fibrillation
Tests village doctor-led care against usual care in older rural adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: A Village Doctor-led Telehealth Supported Trial of Heart Failure Prevention in AF Patients: MIRACLE-AF 2 (Heart Failure Prevention)
Key facts
- Where
- Xuzhou, Yancheng, and Yangzhou, ChinaSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 65 and 80 years old?
Source: NCT07492498, who can take part
Where in China
- Village Clinics in Suining County, Jiangsu ProvinceXuzhou, ChinaTaking people
- Village Clinics in Dongtai City, Jiangsu ProvinceYancheng, ChinaTaking people
- Village Clinics in Jiangdu District, Jiangsu ProvinceYangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Taizhou People's Hospital
- Trial code
- NCT07492498
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
A Village Doctor-led Telehealth Supported Trial of Heart Failure Prevention in AF Patients: MIRACLE-AF 2 (Heart Failure Prevention)
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.
Inclusion: 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: Cardiac dysfunction caused by reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease; Chronic obstructive pulmonary disease complicated by type II respiratory failure; Special populations, such as patients with mental illness; 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; Severe renal insufficiency, defined as creatinine clearance <30 mL/min, or currently receiving dialysis treatment; Expected survival of less than 12 months; Indication for pacemaker implantation but without pacemaker placement.