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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.
Atrial fibrillation (AF) and heart failure (HF) frequently coexist, and preventing incident HF in older AF patients is a critical clinical challenge, particularly in resource-limited rural settings. The MIRACLE-AF III trial is a cluster-randomized controlled trial conducted across 76 village clinics in Jiangsu Province, China, aiming to establish an early-screening and upstream risk-control model for older adults (aged 65-80) with AF but normal cardiac function at baseline. Village clinics are randomized in a 1:1 ratio to provide either conventional routine medical care or a digital-smart integrated management program. In the intervention arm, village doctors utilize a digital health platform integrated with Internet of Things medical devices to deliver guideline-directed medical therapy (GDMT) and ABC-pathway-aligned care, supported by remote tele-consultations from cardiovascular specialists when clinical targets are unmet. Additionally, this integrated approach features a structured multidimensional lifestyle intervention where participants use wearable devices for continuous home monitoring of heart rate and sleep, attend monthly peer-support cardiac rehabilitation sessions at township health centers, and receive automated, tailored behavioral educational content regarding diet, smoking cessation, and sleep hygiene.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital-Smart Integrated Prevention Group | Experimental | Participants in this arm receive a village doctor-led, digital-smart integrated management program. This intervention comprises three key components:
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| Conventional Management | Active Comparator | Participants in this control group receive standard diagnosis and treatment for common chronic diseases (such as hypertension, diabetes, and COPD) provided by primary care physicians. They also receive standard Basic Public Health Services (BPHS), which primarily include quarterly follow-up visits, an annual free physical examination for residents over 65, and the distribution of health education materials. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine-Based Integrated Care Model | Other | This intervention is a village doctor-led, telemedicine-supported integrated care model. It utilizes an Internet of Things (IoT)-enabled digital health platform that automatically collects data from clinic devices and patient wearables (HUAWEI Band 6). The platform provides primary care doctors with clinical decision support for Guideline-Directed Medical Therapy (GDMT) and the atrial fibrillation ABC pathway, facilitating remote tele-consultations with cardiovascular specialists when clinical targets are not met. Furthermore, it includes a structured lifestyle intervention featuring monthly peer-support cardiac rehabilitation sessions at township health centers, along with automated, personalized behavioral education based on quarterly assessments |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in the Overall Life's Essential 8 (LE8) Score | The LE8 score aggregates metrics across two domains: health behaviors (diet, physical activity, nicotine exposure, and sleep health) and health factors (body mass index, non-HDL cholesterol, blood glucose, and blood pressure). Each of the 8 metrics is scored on a scale of 0 to 100. To resolve multiple assessments into a single reported value, the overall LE8 score is calculated as the unweighted arithmetic mean of these 8 components. This calculation yields a single composite score ranging from 0 to 100, where higher scores indicate better cardiovascular health (High: 80-100; Moderate: 50-79; Low: 0-49). This outcome evaluates the mean change in this single aggregated score from baseline. | Baseline and 12 months |
| Number of Participants Experiencing a Composite Cardiovascular Endpoint Event | This outcome reports the total number of participants who experience at least one of the protocol-defined cardiovascular events. To arrive at a single reported value, the following specific clinical events are aggregated into one composite endpoint: cardiovascular death, ischemic or hemorrhagic stroke, hospitalization due to worsening heart failure (HF) or acute coronary syndrome (ACS), and emergency visits due to atrial fibrillation. | Up to 36 months |
| Number of Participants with Incident Asymptomatic Left Ventricular Dysfunction or Heart Failure | This outcome measures the total number of participants who develop incident asymptomatic left ventricular dysfunction with or without heart failure. | Up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Cardiovascular Death | This outcome reports the total number of participants who die from cardiovascular causes. This includes death due to acute myocardial infarction, heart failure, cardiac arrhythmia, cardiac perforation, cardiac tamponade, or other cardiogenic causes, as well as deaths caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism. |
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Inclusion Criteria:
Exclusion Criteria:
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| Conventional Management Group | Other | Participants in the conventional management group receive standard medical care and routine Basic Public Health Services (BPHS) provided by primary care physicians at their local village clinics. This includes standard quarterly follow-up visits for common chronic disease management, an annual free physical examination, and the distribution of general health education materials. Unlike the intervention arm, these participants do not use the IoT-enabled digital health platform, wearable monitoring devices, or participate in the structured multidimensional lifestyle intervention program. |
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| 36 and 48 months |
| Number of Participants Requiring Hospitalization for Cardiovascular or Neurological Events | This outcome measures the number of participants requiring hospitalization in township-level or higher hospitals caused by cardiovascular diseases (such as sudden cardiac death, heart failure, cardiac arrhythmia, acute coronary syndrome, hypertensive emergency) or neurological diseases (ischemic or hemorrhagic stroke, transient ischemic attack). | 36 and 48 months |
| Number of Participants with Emergency Visits for Cardiovascular Events | This outcome reports the number of participants requiring emergency medical visits due to the exacerbation of heart failure or acute coronary syndrome. | 36 and 48 months |
| Number of Participants Experiencing a Stroke | This outcome tracks the number of participants with a new onset of neurological deficit symptoms or signs lasting at least 24 hours, categorized as either ischemic or hemorrhagic stroke confirmed by cranial CT/MRI or a neurological expert group. | 36 and 48 months |
| Number of Participants in Each New York Heart Association (NYHA) Functional Class | This outcome evaluates heart failure symptoms using the NYHA functional classification system. Participants are categorized into classes ranging from I (no limitation of physical activity) to IV (unable to carry on any physical activity without discomfort). | 12 months and 48 months |
| Concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP) | This outcome measures the concentration of NT-proBNP in the blood to assess cardiac function and the progression or onset of heart failure | 12 months, 36 months, and 48 months |
| Mean Left Ventricular Ejection Fraction (LVEF) | This outcome measures the mean LVEF percentage, assessed via echocardiography, to evaluate systolic cardiac function | 12 months and 48 months |
| Number of Participants with Echocardiographic Evidence of Diastolic Cardiac Dysfunction | This outcome reports the number of participants showing structural or functional evidence of diastolic cardiac dysfunction, evaluated via echocardiography. | 12 months and 48 months |
| Mean Change from Baseline in the Overall Life's Essential 8 (LE8) Score at 36 Months | Evaluated as a secondary endpoint in Phase 2 of the study. The LE8 score aggregates 8 cardiovascular health metrics. To arrive at one reported value, the composite LE8 score is calculated as the unweighted arithmetic mean of the 8 components, yielding a single score from 0 to 100. This evaluates the mean change in this composite score. | 36 months |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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