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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Atrial Fibrillation
• Intervention / Treatment: Other: Telemedicine-Based Integrated Care Model; Other: Conventional Management Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 1268
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Jiangsu Taizhou People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Integrated Care; Primary Prevention; Telemedicine Integrated Care
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Heart Failure; Cardiovascular Diseases; Atrial Fibrillation
• Other Study ID Numbers: LSKY 2025-191-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No