NCT07492498

Telemedicine-Based Integrated Care for Heart Failure Prevention in Older Patients With Atrial Fibrillation (MIRACLE-AF III)

Prevention of Incident Heart Failure With a Telemedicine-based Integrated Care Model Among Older Atrial Fibrillation Patients in Rural China: the MIRACLE-AF-Prevention Cluster Randomized Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,268 (estimated)
• Sponsor: Jiangsu Taizhou People's Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atrial Fibrillation
• Heart Failure

Interventions

Type	Name	Description
OTHER	Telemedicine-Based Integrated Care Model	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
OTHER	Conventional Management Group	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2026-03-25
• Last updated: 2026-03-25