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基于远程医疗的整合护理用于老年心房颤动患者心力衰竭预防（MIRACLE-AF III）

2026年7月25日 更新者：Jiangsu Taizhou People's Hospital

基于远程医疗的综合护理模式预防中国农村老年心房颤动患者心力衰竭：MIRACLE-AF-Prevention 整群随机对照试验

本研究的目的是预防居住在中国农村地区、患有心房颤动但当前尚未出现心力衰竭的老年人（年龄65-80岁）发生心力衰竭。 由于心房颤动会显著增加发生心力衰竭的风险，这项整群随机试验旨在验证，与标准护理相比，由村医主导、远程医疗支持的整合护理模式能否改善长期心血管健康。 参与者由其所在的村卫生室分配接受常规医疗护理或数字化智能管理方案。 整合方案包括使用可穿戴设备监测日常健康状况、参与以运动、饮食、戒烟和睡眠为重点的结构化生活方式改善计划，以及在远程心血管专家的支持下接受优化的药物治疗方案。 研究人员将在12个月时使用“生命健康八大要素”评分评估心血管健康的整体改善情况，在36个月时追踪心力衰竭住院或中风等主要心血管事件，并在48个月时评估无症状心功能不全的发生情况。

研究概览

地位

招聘中

条件

干预/治疗

详细说明

心房颤动（AF）与心力衰竭（HF）常并存，在老年AF患者中预防新发HF是一项关键的临床挑战，尤其在资源有限的农村地区。 MIRACLE-AF III试验是在中国江苏省76个村卫生室进行的整群随机对照试验，旨在为基线心功能正常、年龄65-80岁的老年AF患者建立早期筛查和上游风险控制模式。 村卫生室按1:1比例随机分配，提供常规基础医疗服务或数字化智能综合管理方案。 在干预组中，村医利用与物联网医疗设备集成的数字健康平台，提供指南导向的药物治疗（GDMT）和ABC路径协调的护理，并在临床目标未达成时获得心血管专家的远程会诊支持。 此外，该综合方案采用结构化的多维生活方式干预：参与者使用可穿戴设备持续监测家庭心率和睡眠情况，每月在乡镇卫生院参加同伴支持的心脏康复课程，并接收关于饮食、戒烟和睡眠卫生的自动化个性化行为教育内容。

研究类型

介入性

注册 (估计的)

1356

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Dongtai
      • Yancheng、Dongtai、中国、224200
        • 招聘中
        • Village Clinics in Dongtai City, Jiangsu Province
        • 接触：
    • Jiangdu
      • Yangzhou、Jiangdu、中国、225267
        • 招聘中
        • Village Clinics in Jiangdu District, Jiangsu Province
        • 接触：
    • Suining
      • Xuzhou、Suining、中国、221200
        • 招聘中
        • Village Clinics in Suining County, Jiangsu Province
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

不

描述

纳入标准：

  1. 江苏省基层医疗管辖区户籍常住居民，年龄65至80岁；
  2. 具备心电图确诊心房颤动，或专科医师出具的房颤正式诊断证明；
  3. 接受居住地最近基层医疗机构的健康管理；
  4. 能够理解并签署知情同意书。

排除标准：

  1. 明确心力衰竭病史，或经超声心动图和/或NT-proBNP筛查确诊心功能不全。诊断标准：存在典型心力衰竭症状/体征，并伴有左心室射血分数降低（HFrEF，LVEF < 40%）、左心室射血分数轻度降低（HFmrEF，LVEF 40-49%），或左心室射血分数保留但NT-proBNP升高及结构性心脏病改变（HFpEF，LVEF ≥ 50%）；
  2. 预期生存期少于3个月；
  3. 严重肾功能不全患者（Ccr < 30 mL/min）或接受透析治疗者；
  4. 各种可逆性继发原因导致的心功能不全，包括甲状腺功能亢进性心脏病、贫血性心脏病及未矫正的先天性心脏病；
  5. 存在起搏器植入指征但未后续安置设备；
  6. 慢性阻塞性肺疾病（COPD）合并III型呼吸衰竭患者；
  7. 精神疾病患者等特殊人群。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Control Group
Participants in this arm will receive usual chronic disease management according to the National Basic Public Health Service requirements.
其他：Usual Care
Participants in the control group will receive usual chronic disease management according to the National Basic Public Health Service requirements. 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.
实验性的：Intervention Group
The intervention group will receive a village doctor-led integrated management program supported by telemedicine, guideline-based training, and a simplified exercise-based cardiac rehabilitation component, aiming to prevent incident heart failure in elderly rural patients with atrial fibrillation who have preserved cardiac function.
其他：Village-Doctor Led Integrated Care
  1. Village doctors will conduct monthly follow-up, including symptom assessment, vital-sign monitoring, medication adherence support, cardiovascular risk-factor management, health education, and referral when needed.
  2. Village doctors will provide AF management based on the ABC pathway and simplified home-based exercise rehabilitation education.
  3. When clinical deterioration or management difficulties occur, village doctors may use a remote care platform to obtain cardiology specialist consultation and treatment recommendations within 24 hours.
  4. Village doctors will receive standardized training on AF management, anticoagulation, rate/rhythm control, and cardiovascular risk-factor management.
  5. Patients will receive structured education on medication adherence, symptom monitoring, lifestyle modification, exercise rehabilitation, and recognition of warning signs.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Composite Cardiovascular Outcome
大体时间：Baseline to 36 months
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.
Baseline to 36 months
Incidence of Asymptomatic Left Ventricular Dysfunction With or Without Heart Failure
大体时间：Baseline to 48 months
Incidence of asymptomatic left ventricular dysfunction with or without heart failure, assessed by clinical evaluation, NT-proBNP, and echocardiographic evidence of cardiac dysfunction.
Baseline to 48 months
Change in Life's Essential 8 Cardiovascular Health Score
大体时间：Baseline to 12 months
Mean change in Life's Essential 8 cardiovascular health score from baseline to 12 months. The score includes diet, physical activity, nicotine exposure, sleep health, body mass index, non-HDL cholesterol, blood glucose, and blood pressure.
Baseline to 12 months

次要结果测量

结果测量
措施说明
大体时间
Cardiovascular Death
大体时间：12 months after baseline
Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular death
12 months after baseline
Cardiovascular Hospitalization
大体时间：12 months after baseline
Hospitalization due to cardiovascular or neurological diseases at township-level or higher hospitals, including heart failure, cardiac arrhythmia, acute coronary syndrome, hypertensive emergency or urgency, ischemic or hemorrhagic stroke, and transient ischemic attack.
12 months after baseline
Emergency Visit for Cardiovascular Events
大体时间：12 months after baseline
Incidence of emergency visits for cardiovascular events, including exacerbation of heart failure or acute coronary syndrome.
12 months after baseline
ischemic or hemorrhagic Stroke
大体时间：12 months after baseline
All strokes: 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
大体时间：12 month after baseline
The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'
12 month after baseline
Cardiovascular Death
大体时间：36 months after baseline
Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular deathTime
36 months after baseline
Ischemic or hemorrhagic Stroke
大体时间：36 months after baseline
All strokes: ischemic or hemorrhagic Stroke
36 months after baseline
Worsening of heart failure or acute coronary syndrome
大体时间：36 months after baseline
A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions
36 months after baseline
Emergency visit due to AF
大体时间：36 months after baseline
Emergency visit due to AF
36 months after baseline
All-cause mortality
大体时间：36 months after baseline
all-cause death
36 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway
大体时间：36 month after baseline
The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'
36 month after baseline
Cardiovascular Death
大体时间：48 months after baseline
Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular deathTime
48 months after baseline
Ischemic or hemorrhagic Stroke
大体时间：48 months after baseline
All strokes: ischemic or hemorrhagic Stroke
48 months after baseline
Worsening of heart failure or acute coronary syndrome
大体时间：48 months after baseline
A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions
48 months after baseline
Emergency visit due to AF
大体时间：48 months after baseline
Emergency visit due to AF
48 months after baseline
All-cause mortality
大体时间：48 months after baseline
all-cause death
48 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway
大体时间：48 month after baseline
The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'
48 month after baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Jiangsu Taizhou People's Hospital

合作者

The First Affiliated Hospital with Nanjing Medical University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2030年7月1日

研究完成 (估计的)

2030年7月1日

研究注册日期

首次提交

2026年3月16日

首先提交符合 QC 标准的

2026年3月19日

首次发布 (实际的)

2026年3月25日

研究记录更新

最后更新发布 (实际的)

2026年7月28日

上次提交的符合 QC 标准的更新

2026年7月25日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • LSKY 2025-191-01，2026-SR-221

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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