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

NCT07492498 | Not Yet Recruiting DMC

• 1 other identifier: LSKY 2025-191-01
• Study Type: interventional
• Target: 1,268
• Locations: 0 countries
• Sites: N/A

Brief 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

Atrial Fibrillation; Heart Failure

Keywords

Telemedicine Integrated Care; Integrated Care; Primary Prevention; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Number of Participants Experiencing Cardiovascular Death

  36 and 48 months

• Number of Participants Requiring Hospitalization for Cardiovascular or Neurological Events

  36 and 48 months

• Number of Participants with Emergency Visits for Cardiovascular Events

  36 and 48 months

• Number of Participants Experiencing a Stroke

  36 and 48 months

• Number of Participants in Each New York Heart Association (NYHA) Functional Class

  12 months and 48 months

Study Arms (2)

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: 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.

Other: Telemedicine-Based Integrated Care Model

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.

Other: Conventional Management Group

Interventions

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

Digital-Smart Integrated Prevention Group

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.

Conventional Management

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Permanent residents with household registration in primary care jurisdictions of Jiangsu Province, aged 65 to 80 years;
• Availability of an electrocardiogram confirming atrial fibrillation, or an official diagnosis certificate of atrial fibrillation issued by a specialist;
• Receiving healthcare management from the primary medical institution nearest to the place of residence;
• Capable of understanding and signing the informed consent form.

You may not qualify if:

• 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%);
• Expected survival of less than 3 months;
• Patients with severe renal insufficiency (Ccr \< 30 mL/min) or those undergoing dialysis treatment;
• Cardiac dysfunction caused by various reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, and uncorrected congenital heart disease;
• Presence of indications for pacemaker implantation without subsequent device placement;
• Patients with chronic obstructive pulmonary disease (COPD) complicated by type III respiratory failure;
• Special populations such as patients with mental illness.

Sponsors & Collaborators

• Jiangsu Taizhou People's Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 25, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL