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A Village Doctor-led Telehealth Supported Improvement of Outcomes of AF Patients With Heart Failure Due to Reduced or Preserved Ejection Fraction: The MIRACLE-AF 2 Heart Failure Management Trial (MIRACLE AF-HF)

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

The primary objective is to determine whether a telemedicine-supported, village doctor-led integrated management model, AF-HF comorbidity ABC pathway and enhanced patient education, improves clinical outcomes compared with usual care among rural residents aged 65-80 years with AF and HF. The trial will evaluate whether integrated management reduces the MAGGIC HF risk score at 12 months (phase 1) and whether it reduces a 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 over 36 months (phase 2). An extended observational follow-up, the composite cardiovascular endpoint observational follow-up study, will be conducted at Year 6 to evaluate long-term effects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 80
Healthy Volunteers: f
View:
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: 2026-07-26
Estimated Completion Date: 2032-12-30
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-HF comorbidity ABC pathway. 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.
Sponsors
Leads: Jiangsu Taizhou People's Hospital
Collaborators: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov