NCT07492524

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
942

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
42mo 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

Expected
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2029

Last Updated

July 28, 2026

Status Verified

June 1, 2026

Enrollment Period

3.4 years

First QC Date

March 16, 2026

Last Update Submit

July 25, 2026

Conditions

Atrial FibrillationHeart Failure

Outcome Measures

Primary Outcomes (2)

  • Change in MAGGIC Heart Failure Risk Score

    A heart failure prognostic model integrating 13 key predictors, including age, LVEF, systolic blood pressure, BMI, serum creatinine, NYHA functional class, and medication status.

    Baseline to 12 months

  • Composite Cardiovascular Endpoint

    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.

    36 months after baseline

Secondary Outcomes (16)

  • 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

  • +11 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

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 clinical assessment, vital-sign monitoring, medication review, risk screening, health education, and referral when needed. 2. For patients with clinical deterioration or treatment difficulties, village doctors may use a remote care platform to obtain specialist consultation and individualized recommendations. 3. Village doctors will receive standardized training based on the AF ABC pathway and heart failure GDMT principles. 4. Patients will receive structured education on medication adherence, symptom monitoring, lifestyle modification, and recognition of warning signs.

Intervention Group
Usual CareOTHER

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 not qualify if:

  • Expected life expectancy of less than 12 months.
  • Severe renal insufficiency (Ccr \< 30ml/min) or ongoing dialysis treatment.
  • Cardiac insufficiency secondary to correctable causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
  • Indications for pacemaker implantation without having undergone implantation.
  • Chronic obstructive pulmonary disease (COPD) complicated by type II respiratory failure.
  • Special populations, including patients with mental illnesses.

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, 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

  • 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, 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

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 (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2029

Last Updated

July 28, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)