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A Village Doctor-led Telehealth Supported Trial of Heart Failure Prevention in AF Patients: MIRACLE-AF 2 (Heart Failure Prevention)

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

This cluster randomized study aims to compare village doctor-led integrated care versus usual care to improve cardiovascular health, atrial fibrillation management, self-management adherence, and heart failure prevention among older rural patients with atrial fibrillation in China.The primary outcome at 12 months is the change in Life's Essential 8 cardiovascular health score from baseline (phase 1). The primary outcome at 36 months is a composite cardiovascular endpoint including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening HF or acute coronary syndrome, and emergency department visits due to AF (phase 2) . The primary outcome at 48 months is new-incident heart-failure diagnosis (phase 3) .An extended observational follow-up, the new-incident heart-failure diagnosis observational follow-up study, will be conducted at Year 7 to evaluate long-term effects.

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.

• Availability of an electrocardiogram confirming atrial fibrillation, or an official diagnosis certificate of atrial fibrillation issued by a specialist.

• Receiving healthcare management from a primary medical institution near the place of residence.

• Able to understand and sign the informed consent form.

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: 2033-12-30
Participants
Target number of participants: 1356
Treatments
Experimental: 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.
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

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