Novel Model of Integrated Care of Older Patients With Atrial Fibrillation and Heart Failure in Rural China (MIRACLE-AFHF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 942
- 试验地点
- 3
- 主要终点
- Change in MAGGIC Heart Failure Risk Score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. The village clinics need to be willing and able to provide integrated care to their patients with atrial fibrillation;
- •The village doctors from one village clinic serves all AF patients from 3-5 nearby villages;
- •The village doctors are trained to have a fundamental understanding of telemedicine;
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention Group
Participants in this arm will receive village-doctor led integrated care for atrial fibrillation and heart failure. Village doctors will receive standardized training based on the AF ABC pathway and heart failure GDMT principles. Patients will receive structured self-management education focused on medication adherence, symptom monitoring, lifestyle modification, and recognition of warning signs.
干预措施: Village-Doctor Led Integrated Care (Other)
Control Group
Participants in this arm will receive usual chronic disease management according to the National Basic Public Health Service requirements.
干预措施: Usual Care (Other)
结局指标
主要结局
Change in MAGGIC Heart Failure Risk Score
时间窗: Baseline to 12 months
A heart failure prognostic model integrating 13 key predictors, including age, LVEF, systolic blood pressure, BMI, serum creatinine, NYHA functional class, and medication status.
Composite Cardiovascular Endpoint
时间窗: 36 months after baseline
Composite cardiovascular endpoint, including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening heart failure or acute coronary syndrome, and emergency visits due to atrial fibrillation.
次要结局
- Cardiovascular Death(12 months after baseline)
- Cardiovascular Hospitalization(12 months after baseline)
- Emergency Visit for Cardiovascular Events(12 months after baseline)
- ischemic or hemorrhagic Stroke(12 months after baseline)
- The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care(12 month after baseline)
- GDMT medication utilization rate(12months after baseline)
- Cardiovascular Death(36 months after baseline)
- Ischemic or hemorrhagic Stroke(36 months after baseline)
- Worsening of heart failure or acute coronary syndrome(36 months after baseline)
- Emergency visit due to AF(36 months after baseline)
- All-cause mortality(36 months after baseline)
- The proportion of patients who met all the three criteria for the ABC pathway(36 month after baseline)
- Change in MAGGIC Heart Failure Risk Score(Baseline to 36 months)
- GDMT Score(Baseline to 12 months)
- GDMT Score(Baseline to 36 months)
- GDMT medication utilization rate(36 months after baseline)