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

Jiangsu Taizhou People's Hospital

Status: Not yet enrolling

Conditions: Atrial Fibrillation; Heart Failure

Treatments: Other: Conventional Management; Behavioral: Digital Intelligent Integrated Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07492524

LSKY 2025-192-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,227 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,227 participants in 2 patient groups

Digital Intelligent Integrated Management Group

Experimental group

Description:

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)

Treatment:

Behavioral: Digital Intelligent Integrated Management

Conventional Management Group

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Management