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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Village Clinics in Suining County, Jiangsu Province
RECRUITING
Xuzhou
Village Clinics in Dongtai City, Jiangsu Province
RECRUITING
Yancheng
Village Clinics in Jiangdu District, Jiangsu Province
RECRUITING
Yangzhou
Contact Information
Primary
Ming Chu
chuming@njmu.edu.cn
13814010410
Time Frame
Start Date: 2026-08-01
Estimated Completion Date: 2029-12-30
Participants
Target number of participants: 942
Treatments
Experimental: 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.
Active_comparator: Control Group
Participants in this arm will receive usual chronic disease management according to the National Basic Public Health Service requirements.
Related Therapeutic Areas
Sponsors
Leads: Jiangsu Taizhou People's Hospital
Collaborators: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov