NCT07492524

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,227 (estimated)
• Sponsor: Jiangsu Taizhou People's Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Atrial Fibrillation
• Heart Failure

Interventions

Type	Name	Description
BEHAVIORAL	Digital Intelligent Integrated Management	This multi-component intervention includes: 1. A digital chronic disease management system for AF screening and intelligent decision-making. 2. Structured multidimensional lifestyle intervention featuring monthly peer-support group cardiac rehabilitation (aerobic, resistance, and flexibility training). 3. Smart wearable device monitoring (HUAWEI Band 6) for heart rate and step counts. 4. Personalized health education delivered via digital articles and videos. 5. Integrated management services providing guideline-directed medical therapy (GDMT) for heart failure and the ABC pathway for AF
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.

Timeline

• Start date: 2026-03-25
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2026-03-25
• Last updated: 2026-03-25