Novel Model of Integrated Care of Older Patients With Atrial Fibrillation and Heart Failure in Rural China (MIRACLE-AFHF)

Обзор

This cluster randomization study aims to compare village-doctor led integrated care versus usual care to improve heart failure risk management, guideline-directed medical therapy, self-management adherence, and clinical outcomes for older patients with atrial fibrillation and heart failure in rural China.

Подробное описание

BACKGROUND Atrial fibrillation (AF) and heart failure (HF) frequently coexist and interact bidirectionally, creating a vicious cycle that increases the risks of hospitalization, stroke, cardiovascular death, and all-cause mortality in older adults. Although adherence to the Atrial Fibrillation Better Care (ABC) pathway has been shown to improve AF management, older patients with coexisting AF and HF in rural China remain particularly vulnerable because of inadequate HF screening and risk stratification, suboptimal implementation of guideline-directed medical therapy (GDMT), and insufficient long-term follow-up.

China's rural healthcare system relies heavily on village doctors for the delivery of primary care. However, village doctors often have limited access to clinical resources, standardized training, and specialist support, which may hinder the optimal management of patients with AF-HF comorbidity. A village-doctor-led integrated care model incorporating regular follow-up, medication review, clinical risk monitoring, guideline-based treatment, timely specialist consultation, and structured patient education may therefore improve disease management and clinical outcomes in this high-risk population.

AIM OF THE STUDY This cluster-randomized trial aims to evaluate whether village-doctor-led integrated care, compared with usual care, improves HF risk management, adherence to guideline-recommended treatment, and clinical outcomes among older adults with coexisting AF and HF in rural China. STUDY DESIGN This is a prospective, cluster-randomized, open-label, parallel-group clinical trial conducted in rural areas of Jiangsu Province, China. The study plans to enroll rural residents aged 65-80 years with documented AF and either previously diagnosed or screening-detected HF from approximately 50 village clinics. Village clinics will be randomized in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will receive village-doctor-led integrated care, including monthly follow-up; monitoring of symptoms, vital signs, and clinical risk factors; medication review; standardized risk assessment; guideline-based management according to the AF ABC pathway and HF GDMT recommendations; specialist consultation when clinically indicated; and structured education on self-management. Participants in the control group will receive usual chronic disease management in accordance with the requirements of China's National Basic Public Health Service Program. All participants will be followed for up to 36 months

Вмешательства

• Другое Village-Doctor Led Integrated Care
  1. Village doctors will conduct monthly follow-up, including clinical assessment, vital-sign monitoring, medication review, risk screening, health education, and referral when needed. 2. For patients with clinical deterioration or treatment difficulties, village doctors may use a remote care platform to obtain specialist consultation and individualized recommendations. 3. Village doctors will receive standardized training based on the AF ABC pathway and heart failure GDMT principles. 4. Patients
• Другое Usual Care
  Usual care includes routine follow-up, general health education, medication registration, and standard referral procedures provided by local primary care providers. Participants will not receive the structured village-doctor led integrated care program.

Первичные конечные точки

• Change in MAGGIC Heart Failure Risk Score [Срок оценки: Baseline to 12 months]
• Composite Cardiovascular Endpoint [Срок оценки: 36 months after baseline]

Вторичные конечные точки (12)

• Cardiovascular Death [Срок оценки: 12 months after baseline]
• Cardiovascular Hospitalization [Срок оценки: 12 months after baseline]
• Emergency Visit for Cardiovascular Events [Срок оценки: 12 months after baseline]
• ischemic or hemorrhagic Stroke [Срок оценки: 12 months after baseline]
• The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care [Срок оценки: 12 month after baseline]
• GDMT medication utilization rate [Срок оценки: 12months after baseline]
• Cardiovascular Death [Срок оценки: 36 months after baseline]
• Ischemic or hemorrhagic Stroke [Срок оценки: 36 months after baseline]
• Worsening of heart failure or acute coronary syndrome [Срок оценки: 36 months after baseline]
• Emergency visit due to AF [Срок оценки: 36 months after baseline]
• All-cause mortality [Срок оценки: 36 months after baseline]
• The proportion of patients who met all the three criteria for the ABC pathway [Срок оценки: 36 month after baseline]

Критерии участия

1\. The village clinics need to be willing and able to provide integrated care to their patients with atrial fibrillation; 2. The village doctors from one village clinic serves all AF patients from 3-5 nearby villages; 3. The village doctors are trained to have a fundamental understanding of telemedicine; 4. Patients are eligible for participation if 1)they 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.

Критерии исключения

• Expected life expectancy of less than 12 months.
• Severe renal insufficiency (Ccr < 30ml/min) or ongoing dialysis treatment.
• Cardiac insufficiency secondary to correctable causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
• Indications for pacemaker implantation without having undergone implantation.
• Chronic obstructive pulmonary disease (COPD) complicated by type II respiratory failure.
• Special populations, including patients with mental illnesses.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Village Clinics in Dongtai City, Jiangsu Province — Yancheng
• Village Clinics in Jiangdu District, Jiangsu Province — Yangzhou
• Village Clinics in Suining County, Jiangsu Province — Xuzhou

Публикации

• Li M, Chu M, Shen Y, Zhang S, Yin X, Yang S, Lip GYH, Chen M; MIRACLE-AF Trial Investigators. A Novel Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China. JACC Asia. 2024 Jul 30;4(10):764-773. doi: 10.1016/j.jacasi.2024.07.006. eCollection 2024 Oct. PMID 39553909
• Chu M, Zhang S, Gong J, Yang S, Yang G, Sun X, Wu D, Xia Y, Jiao J, Peng X, Peng Z, Hong L, Wang Z, Li M, Lip GYH, Chen M; MIRACLE-AF Investigators. Telemedicine-based integrated management of atrial fibrillation in village clinics: a cluster randomized trial. Nat Med. 2025 Apr;31(4):1276-1285. doi: 10.1038/s41591-025-03511-2. Epub 2025 Feb 21. PMID 39984634
• Li M, Chen Y, Chu M, Zhang S, Yang S, Lip GYH, Chen M. Village Doctor-Led Telemedicine for Rural Patients Aged 75 Years and Older With AF: A Prespecified Secondary Analysis of the MIRACLE-AF Trial. JAMA Netw Open. 2026 Mar 2;9(3):e261385. doi: 10.1001/jamanetworkopen.2026.1385. PMID 41817526

Идентификаторы

NCT: NCT07492524 · LSKY 2025-192-01，2026-SR-177

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗