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

Jiangsu Taizhou People's Hospital

Status: Not yet enrolling

Conditions: Atrial Fibrillation; Heart Failure

Treatments: Other: Telemedicine-Based Integrated Care Model; Other: Conventional Management Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07492498

LSKY 2025-191-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,268 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Permanent residents with household registration in primary care jurisdictions of Jiangsu Province, aged 65 to 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 the primary medical institution nearest to the place of residence;
4. Capable of understanding and signing the informed consent form.

Exclusion criteria

1. A definite history of heart failure, or a confirmed diagnosis of cardiac dysfunction via echocardiography and/or NT-proBNP screening. Diagnostic criteria: Presence of typical heart failure symptoms/signs, accompanied by either reduced left ventricular ejection fraction (HFrEF, LVEF < 40%), mildly reduced left ventricular ejection fraction (HFmrEF, LVEF 40-49%), or preserved left ventricular ejection fraction with elevated NT-proBNP and structural heart disease changes (HFpEF, LVEF ≥ 50%);
2. Expected survival of less than 3 months;
3. Patients with severe renal insufficiency (Ccr < 30 mL/min) or those undergoing dialysis treatment;
4. Cardiac dysfunction caused by various reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, and uncorrected congenital heart disease;
5. Presence of indications for pacemaker implantation without subsequent device placement;
6. Patients with chronic obstructive pulmonary disease (COPD) complicated by type III respiratory failure;
7. Special populations such as patients with mental illness.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,268 participants in 2 patient groups

Digital-Smart Integrated Prevention Group

Experimental group

Description:

Participants in this arm receive a village doctor-led, digital-smart integrated management program. This intervention comprises three key components: 1. A digital chronic disease management system utilizing an IoT gateway and wearable devices (HUAWEI Band 6) for continuous health monitoring. 2. A structured multidimensional lifestyle intervention that includes monthly peer-support cardiac rehabilitation sessions and tailored behavioral education on diet, smoking, and sleep. 3. Integrated care services that provide guideline-directed medical therapy (GDMT) and access to remote tele-consultations with cardiovascular specialists.

Treatment:

Other: Telemedicine-Based Integrated Care Model

Conventional Management

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Management Group