NCT07492498

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,356

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
48mo left

Started Aug 2026

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

3.9 years

First QC Date

March 16, 2026

Last Update Submit

July 25, 2026

Conditions

Atrial FibrillationHeart Failure

Outcome Measures

Primary Outcomes (3)

  • Change in Life's Essential 8 Cardiovascular Health Score

    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

  • Composite Cardiovascular Outcome

    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

    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

Secondary Outcomes (17)

  • 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

  • +12 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Village-Doctor Led Integrated Care

Control Group

ACTIVE COMPARATOR

Participants in this arm will receive usual chronic disease management according to the National Basic Public Health Service requirements.

Other: Usual Care

Interventions

Village-Doctor Led Integrated CareOTHER

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.

Intervention Group
Usual CareOTHER

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.

Control Group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • A definite history of heart failure, or confirmed cardiac dysfunction or heart failure based on echocardiography and/or NT-proBNP screening. Diagnostic criteria include typical heart failure symptoms or signs with 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 evidence (HFpEF, LVEF ≥50%, with at least one of the following: LAVI \>40 mL/m², E/e' ≥15, or TRV \>2.8 m/s).
  • Expected survival of less than 12 months.
  • Severe renal insufficiency, defined as creatinine clearance \<30 mL/min, or currently receiving dialysis treatment.
  • Cardiac dysfunction caused by reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
  • Indication for pacemaker implantation but without pacemaker placement.
  • Chronic obstructive pulmonary disease complicated by type II respiratory failure.
  • Special populations, such as patients with mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Village Clinics in Dongtai City, Jiangsu Province

Yancheng, Dongtai, 224200, China

RECRUITING

Village Clinics in Jiangdu District, Jiangsu Province

Yangzhou, Jiangdu, 225267, China

RECRUITING

Village Clinics in Suining County, Jiangsu Province

Xuzhou, Suining, 221200, China

RECRUITING

Related Publications (3)

  • Li M, Chen Y, Chu M, Zhang S, Yang S, Lip GYH, Chen M. Village Doctor-Led Telemedicine for Rural Patients Aged 75 Years and Older With AF: A Prespecified Secondary Analysis of the MIRACLE-AF Trial. JAMA Netw Open. 2026 Mar 2;9(3):e261385. doi: 10.1001/jamanetworkopen.2026.1385.

    PMID: 41817526BACKGROUND

  • Chu M, Zhang S, Gong J, Yang S, Yang G, Sun X, Wu D, Xia Y, Jiao J, Peng X, Peng Z, Hong L, Wang Z, Li M, Lip GYH, Chen M; MIRACLE-AF Investigators. Telemedicine-based integrated management of atrial fibrillation in village clinics: a cluster randomized trial. Nat Med. 2025 Apr;31(4):1276-1285. doi: 10.1038/s41591-025-03511-2. Epub 2025 Feb 21.

    PMID: 39984634BACKGROUND

  • Li M, Chu M, Shen Y, Zhang S, Yin X, Yang S, Lip GYH, Chen M; MIRACLE-AF Trial Investigators. A Novel Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China. JACC Asia. 2024 Jul 30;4(10):764-773. doi: 10.1016/j.jacasi.2024.07.006. eCollection 2024 Oct.

    PMID: 39553909BACKGROUND

MeSH Terms

Conditions

Atrial FibrillationHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ming Chu

CONTACT

13814010410chuming@njmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 25, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)