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

NCT07492498 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1268

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Jiangsu Taizhou People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2030-04-01
Completion
2030-04-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07492498 on ClinicalTrials.gov