Telemedicine-based Integrated Management of Atrial Fibrillation and Heart Failure in Older Patients in Village Clinics

Telemedicine-based Integrated Management of Atrial Fibrillation and Heart Failure in Older Patients in Village Clinics: the MIRACLE-AF II Cluster Randomized Trial

The goal of this cluster-randomized clinical trial is to evaluate a telemedicine-based, village doctor-led integrated management program for older adults (aged 65-80 years) who have both atrial fibrillation (AF) and heart failure (HF) in rural clinics in China. It aims to answer whether the digitally-supported program improves heart failure prognosis, assessed by the MAGGIC score, at 12 months , and reduces the risk of composite endpoint events, such as cardiovascular death, stroke, or heart failure hospitalization, over 36 months compared to conventional routine care. In this study, village clinics will be randomly assigned to either the intervention group or the control group. Participants in the control group will receive conventional routine care and basic public health services , while participants in the intervention group will receive a comprehensive management program led by village doctors. This intervention includes optimized medication treatment guided by a digital health platform with remote expert support , as well as a structured multidimensional lifestyle intervention featuring peer-support group exercises, smart wearable device monitoring, and personalized health education.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Atrial Fibrillation
• Intervention / Treatment: Behavioral: Digital Intelligent Integrated Management; Other: Conventional Management

Detailed Description

Atrial fibrillation (AF) and heart failure (HF) frequently coexist and mutually reinforce one another, forming a "vicious cycle" that is particularly destructive in older adults. Older patients with AF are at high risk for HF progression, and AF-HF comorbidity is a central determinant of long-term prognosis. In rural China, effective prevention and long-term management face practical bottlenecks, including inadequate early HF screening and insufficient intensity of targeted prevention. Previous studies suggest that "process-oriented" integration alone, such as the standard ABC pathway, may be insufficient for rural AF patients in whom HF risk is dominant.

To address these gaps, the MIRACLE-AF II study aims to establish a village doctor-led model that integrates guideline-directed medical therapy (GDMT) with multidimensional lifestyle interventions, supported by telemedicine and intelligent decision assistance. By integrating early HF screening, medication access, and a scalable lifestyle intervention (including peer-group cardiac rehabilitation, behavioral education, and smart wearable device monitoring) into a tele-supported workflow, this project seeks to effectively improve clinical outcomes for older patients.

This is a cluster-randomized controlled trial conducted in rural areas of Jiangsu Province, China. Village clinics are randomized in a 1:1 ratio to either a digital intelligent integrated management group (intervention) or a conventional management group (control). The study enrolls permanent residents aged 65 to 80 years with confirmed AF and a documented history or screening-based diagnosis of HF. The trial is divided into two phases: a 12-month follow-up to compare the HF prognosis score (MAGGIC score) between the two groups, and a 36-month follow-up to compare composite endpoint events, including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization due to worsening HF or acute coronary syndrome (ACS), and emergency visits for AF.

• Study Type: Interventional
• Enrollment (Estimated): 1227
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Permanent residents with local household registration at the primary level in Jiangsu Province, aged 65-80 years.
2. Electrocardiogram (ECG) confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist.
3. A documented history of HF or a diagnosis of HF based on echocardiography and/or NT-proBNP screening, defined by the presence of typical HF symptoms and/or signs, together with one of the following: 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%, meeting at least one of the following criteria: LAV 40 ml/m², E/e' ≥ 15, or TRV > 2.8 m/s).
4. Management by a village clinic near the participant's place of residence.
5. Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

1. Expected life expectancy of less than 3 months.
2. Severe renal insufficiency (Ccr < 30ml/min) or ongoing dialysis treatment.
3. Cardiac insufficiency secondary to correctable causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
4. Indications for pacemaker implantation without having undergone implantation.
5. Chronic obstructive pulmonary disease (COPD) complicated by type II respiratory failure.
6. Special populations, including patients with mental illnesses.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Intelligent Integrated Management Group; Participants receive village doctor-led integrated management supported by digital technology. This includes a digital health platform for intelligent decision-making, remote specialist support, and structured multidimensional lifestyle interventions (cardiac rehabilitation, smart wearable device monitoring, and personalized health education)	Behavioral: Digital Intelligent Integrated Management; This multi-component intervention includes: A digital chronic disease management system for AF screening and intelligent decision-making.; Structured multidimensional lifestyle intervention featuring monthly peer-support group cardiac rehabilitation (aerobic, resistance, and flexibility training).; Smart wearable device monitoring (HUAWEI Band 6) for heart rate and step counts.; Personalized health education delivered via digital articles and videos.; Integrated management services providing guideline-directed medical therapy (GDMT) for heart failure and the ABC pathway for AF
Active Comparator: Conventional Management Group; Participants receive standard diagnosis and treatment for common chronic diseases (hypertension, diabetes, and COPD) and Basic Public Health Services (BPHS) provided by primary care physicians according to national specifications.	Other: Conventional Management; Participants in the control group receive standard diagnosis and treatment for common chronic diseases (hypertension, diabetes, and chronic obstructive pulmonary disease) and Basic Public Health Services (BPHS) provided by primary care physicians. The 14 government-provided BPHS items primarily include quarterly follow-up visits for patients with hypertension, diabetes, and COPD, an annual free physical examination for residents aged 65 years and older, and the distribution of health education materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score	Risk stratification is performed using the MAGGIC risk score, a validated integer scoring system that integrates 13 key predictors: age, gender, NYHA classification, left ventricular ejection fraction (LVEF), smoking status, diabetes, COPD, heart failure diagnosed within the past 18 months, systolic blood pressure (SBP), body mass index (BMI), serum creatinine level, use of beta-blockers, and use of ACEI/ARB. The cumulative score ranges from 0 to 50. Higher scores indicate a higher risk of mortality and a worse prognosis.	Baseline to 12 months
Number of Participants Experiencing a Composite Cardiovascular Endpoint	This is a composite endpoint tracking the first occurrence of any of the following events: cardiovascular death, ischemic or hemorrhagic stroke, hospitalization due to worsening heart failure (HF) or acute coronary syndrome (ACS), and emergency visits for atrial fibrillation (AF).	Up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Cardiovascular Death at 12 Months	Incidence of cardiovascular death, defined as death due to acute myocardial infarction, heart failure, cardiac arrhythmia, cardiac perforation, cardiac tamponade, or other cardiogenic causes. Deaths caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism are also classified as cardiovascular deaths	Up to 12 months
Number of Participants with Cardiovascular-Related Hospitalization at 12 Months	Incidence of hospitalization in township-level or higher hospitals caused by cardiovascular diseases (sudden cardiac death, heart failure, cardiac arrhythmia, acute coronary syndrome, hypertensive emergency or hypertensive subemergency, etc.) or neurological diseases (ischemic or hemorrhagic stroke, transient ischemic attack)	Up to 12 months
Number of Participants with Emergency Visits for Cardiovascular Events at 12 Months	Incidence of emergency visits for cardiovascular events, including exacerbation of heart failure or acute coronary syndrome.	Up to 12 months
Number of Participants with Stroke at 12 Months	Incidence of stroke, defined as a new onset of neurological deficit symptoms or signs with a duration of at least 24 hours, caused by the sudden rupture of cerebral blood vessels or insufficient cerebral blood perfusion due to vascular occlusion, which is confirmed by cranial CT/MRI evidence or diagnosed by a neurological expert group.	Up to 12 months
Number of Participants with Cardiovascular Death at 36 Months	Incidence of cardiovascular death, defined as death due to acute myocardial infarction, heart failure, cardiac arrhythmia, cardiac perforation, cardiac tamponade, or other cardiogenic causes. Deaths caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism are also classified as cardiovascular deaths	Up to 36 months
Number of Participants with Cardiovascular-Related Hospitalization at 36 Months	Incidence of hospitalization in township-level or higher hospitals caused by cardiovascular diseases (sudden cardiac death, heart failure, cardiac arrhythmia, acute coronary syndrome, hypertensive emergency or hypertensive subemergency, etc.) or neurological diseases (ischemic or hemorrhagic stroke, transient ischemic attack).	Up to 36 months
Number of Participants with Emergency Visits for Cardiovascular Events at 36 Months	Incidence of emergency visits for cardiovascular events, including exacerbation of heart failure or acute coronary syndrome.	Up to 36 months
Number of Participants with Stroke at 36 Months	Incidence of stroke, defined as a new onset of neurological deficit symptoms or signs with a duration of at least 24 hours, caused by the sudden rupture of cerebral blood vessels or insufficient cerebral blood perfusion due to vascular occlusion, which is confirmed by cranial CT/MRI evidence or diagnosed by a neurological expert group.	Up to 36 months
Change in Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score at 36 Months	Risk stratification will be performed using the MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) risk score. This validated integer scoring system integrates 13 key predictors to calculate a cumulative risk score ranging from 0 to 50. Higher scores indicate a worse prognosis.	Baseline and 36 months

Collaborators and Investigators

• Sponsor: Jiangsu Taizhou People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

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

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: LSKY 2025-192-01

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