AzTrials
AzTrials

Atrial FibrillationNCT07492524

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)

A study testing Village-Doctor Led Integrated Care in people with Atrial Fibrillation and Heart Failure, run by Jiangsu Taizhou People's Hospital at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 to 80 years
Conditions the study is for
Atrial Fibrillation, Heart Failure
What is being tested?
Village-Doctor Led Integrated Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
942 participants
Where
3 sitesChina
Study dates
26 Jul 2026to 30 Dec 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China3 sites, 3 recruiting
  • Village Clinics in Suining County, Jiangsu Province

    Xuzhou, Suining, 221200

    Wensu Chen, 15050848274, Chen.wensu@163.com

    Recruiting
  • Village Clinics in Dongtai City, Jiangsu Province

    Yancheng, Dongtai, 224200

    Cheng Wu, 18012515515, wucheng1413@163.com

    Recruiting
  • Village Clinics in Jiangdu District, Jiangsu Province

    Yangzhou, Jiangdu, 225267

    Ming Chu, 13814010410, chuming@njmu.edu.cn

    Recruiting

Other trials in China

About this study

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.

Read the detailed description

BACKGROUND Atrial fibrillation (AF) and heart failure (HF) frequently coexist and interact bidirectionally, creating a vicious cycle that increases the risks of hospitalization, stroke, cardiovascular death, and all-cause mortality in older adults. Although adherence to the Atrial Fibrillation Better Care (ABC) pathway has been shown to improve AF management, older patients with coexisting AF and HF in rural China remain particularly vulnerable because of inadequate HF screening and risk stratification, suboptimal implementation of guideline-directed medical therapy (GDMT), and insufficient long-term follow-up.

China's rural healthcare system relies heavily on village doctors for the delivery of primary care. However, village doctors often have limited access to clinical resources, standardized training, and specialist support, which may hinder the optimal management of patients with AF-HF comorbidity. A village-doctor-led integrated care model incorporating regular follow-up, medication review, clinical risk monitoring, guideline-based treatment, timely specialist consultation, and structured patient education may therefore improve disease management and clinical outcomes in this high-risk population.

AIM OF THE STUDY This cluster-randomized trial aims to evaluate whether village-doctor-led integrated care, compared with usual care, improves HF risk management, adherence to guideline-recommended treatment, and clinical outcomes among older adults with coexisting AF and HF in rural China. STUDY DESIGN This is a prospective, cluster-randomized, open-label, parallel-group clinical trial conducted in rural areas of Jiangsu Province, China. The study plans to enroll rural residents aged 65-80 years with documented AF and either previously diagnosed or screening-detected HF from approximately 50 village clinics. Village clinics will be randomized in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will receive village-doctor-led integrated care, including monthly follow-up; monitoring of symptoms, vital signs, and clinical risk factors; medication review; standardized risk assessment; guideline-based management according to the AF-HF comorbidity ABC pathway; specialist consultation when clinically indicated; and structured education on self-management. Participants in the control group will receive usual chronic disease management in accordance with the requirements of China's National Basic Public Health Service Program.

Being tested
Village-Doctor Led Integrated Care, Usual Care
Medical subject headings
Atrial Fibrillation, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Village-Doctor Led Integrated CareOther

    1. Village doctor-led management: At least one follow-up visit per month will be conducted either at the village clinic or in the patient's home, including assessment of clinical status, monitoring of vital signs, medication review, risk screening, and health education.
    2. Telemedicine specialist support: When symptoms fluctuate, treatment adjustment is difficult or a management problem arises, the village doctor may upload symptoms, ECG recordings, blood pressure, heart rate and examination materials through a dedicated telemedicine platform.
    3. Standardised guideline training. Village doctors will receive tiered training based on the AF-HF comorbidity ABC pathway.
    4. Patient education: Participants will receive the study team's 18 core AF-HF self-management messages through monthly face-to-face education, regular short-message reminders and illustrated brochures, reinforcing medication adherence, symptom monitoring, salt and fluid restriction, exercise rehabilitation.
  • 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.

Study groups in NCT07492524
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants 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.
Receives: Other: Village-Doctor Led Integrated Care
Control GroupActive comparatorParticipants in this arm will receive usual chronic disease management according to the National Basic Public Health Service requirements.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome of Phase 1: 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.

    Measured: Baseline to 12 months

  2. Primary Outcome of Phase 2: 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.

    Measured: 36 months after baseline

  3. Primary Outcome of Extension Study: 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.

    Measured: 72 months after baseline

Secondary outcomes (25)
  1. Cardiovascular Death

    Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular death

    Measured: 12 months after baseline

  2. Cardiovascular Hospitalization

    Hospitalization due to cardiovascular or neurological diseases at township-level or higher hospitals, including heart failure, cardiac arrhythmia, acute coronary syndrome, hypertensive emergency or urgency, ischemic or hemorrhagic stroke, and transient ischemic attack.

    Measured: 12 months after baseline

  3. Emergency Visit for Cardiovascular Events

    Incidence of emergency visits for cardiovascular events, including exacerbation of heart failure or acute coronary syndrome.

    Measured: 12 months after baseline

  4. ischemic or hemorrhagic Stroke

    All strokes: ischemic or hemorrhagic Stroke

    Measured: 12 months after baseline

  5. The proportion of patients who met all the three criteria for the AF-HF comorbidity ABC pathway adherence

    Proportion of participants meeting all three AF-HF comorbidity ABC criteria. 'A' (avoid stroke): appropriate oral anticoagulation according to guideline indications, defined as use of an appropriately dosed direct oral anticoagulant or warfarin with time in therapeutic range >65%.Patients who were not properly treated with OACs are considered as 'A non-compliant'. 'B' (Better functional status): Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. 'C' (comorbidity and cardiovascular risk-factor management): 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'.

    Measured: 12 month after baseline

  6. GDMT medication utilization rate

    The proportion of patients who are eligible for guideline-directed medical therapy (GDMT) and actually receive GDMT within 12 Months. Single-class prescription rate: Prescription rate for a given GDMT drug class = (number of patients prescribed that drug class) / (number of patients eligible for that drug class) × 100%. At least one GDMT class prescription rate: At least one GDMT prescription rate = (number of patients prescribed at least one GDMT drug class) / (total number of patients eligible for GDMT) × 100%. Quadruple GDMT prescription rate: Quadruple therapy prescription rate = (number of patients simultaneously prescribed ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) / (number of patients eligible for all four drug classes) × 100%.

    Measured: 12months after baseline

  7. GDMT Score

    β-blockers are scored as 0, 1, or 2 points for no use, use at <50% of the target dose, or use at ≥50% of the target dose, respectively. For renin-angiotensin system inhibitors, no use is scored as 0 points; ACEI/ARB therapy at <50% or ≥50% of the target dose is scored as 1 or 2 points, respectively; and ARNI therapy at any dose is scored as 3 points. Mineralocorticoid receptor antagonists and SGLT2 inhibitors are each scored as 0 points when not used and 2 points when used at any dose. Ivabradine and vericiguat are each scored as 0 points when not used and 1 point when used at any dose. The scores for all medication classes are summed to obtain the total GDMT score, with a higher score indicating a greater degree of GDMT implementation. Target doses are determined according to the relevant heart failure guidelines.

    Measured: Baseline to 12 months

  8. Cardiovascular Death

    Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular deathTime

    Measured: 36 months after baseline

  9. Ischemic or hemorrhagic Stroke

    All strokes: ischemic or hemorrhagic Stroke

    Measured: 36 months after baseline

  10. Worsening of heart failure or acute coronary syndrome

    A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions

    Measured: 36 months after baseline

  11. Emergency visit due to AF

    Emergency visit due to AF

    Measured: 36 months after baseline

  12. All-cause mortality

    all-cause death

    Measured: 36 months after baseline

  13. The proportion of patients who met all the three criteria for the ABC pathway

    The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'

    Measured: 36 month after baseline

  14. GDMT medication utilization rate

    The proportion of patients who are eligible for guideline-directed medical therapy (GDMT) and actually receive GDMT within 36 months. Single-class prescription rate: Prescription rate for a given GDMT drug class = (number of patients prescribed that drug class) / (number of patients eligible for that drug class) × 100%. At least one GDMT class prescription rate: At least one GDMT prescription rate = (number of patients prescribed at least one GDMT drug class) / (total number of patients eligible for GDMT) × 100%. Quadruple GDMT prescription rate: Quadruple therapy prescription rate = (number of patients simultaneously prescribed ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) / (number of patients eligible for all four drug classes) × 100%.

    Measured: 36 months after baseline

  15. Change in MAGGIC Heart Failure Risk Score

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

    Measured: Baseline to 36 months

  16. GDMT Score

    β-blockers are scored as 0, 1, or 2 points for no use, use at <50% of the target dose, or use at ≥50% of the target dose, respectively. For renin-angiotensin system inhibitors, no use is scored as 0 points; ACEI/ARB therapy at <50% or ≥50% of the target dose is scored as 1 or 2 points, respectively; and ARNI therapy at any dose is scored as 3 points. Mineralocorticoid receptor antagonists and SGLT2 inhibitors are each scored as 0 points when not used and 2 points when used at any dose. Ivabradine and vericiguat are each scored as 0 points when not used and 1 point when used at any dose. The scores for all medication classes are summed to obtain the total GDMT score, with a higher score indicating a greater degree of GDMT implementation. Target doses are determined according to the relevant heart failure guidelines.

    Measured: Baseline to 36 months

  17. Cardiovascular Death

    Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular deathTime.

    Measured: 72 months after baseline

  18. Ischemic or hemorrhagic Stroke

    All strokes: ischemic or hemorrhagic Stroke

    Measured: 72 months after baseline

  19. Worsening of heart failure or acute coronary syndrome

    A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions

    Measured: 72 months after baseline

  20. Emergency visit due to AF

    Emergency visit due to AF

    Measured: 72 months after baseline

  21. All-cause mortality

    all-cause death

    Measured: 72 months after baseline

  22. The proportion of patients who met all the three criteria for the ABC pathway

    The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'

    Measured: 72 month after baseline

  23. GDMT medication utilization rate

    The proportion of patients who are eligible for guideline-directed medical therapy (GDMT) and actually receive GDMT within 36 months. Single-class prescription rate: Prescription rate for a given GDMT drug class = (number of patients prescribed that drug class) / (number of patients eligible for that drug class) × 100%. At least one GDMT class prescription rate: At least one GDMT prescription rate = (number of patients prescribed at least one GDMT drug class) / (total number of patients eligible for GDMT) × 100%. Quadruple GDMT prescription rate: Quadruple therapy prescription rate = (number of patients simultaneously prescribed ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) / (number of patients eligible for all four drug classes) × 100%.

    Measured: 72 months after baseline

  24. 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.

    Measured: Baseline to 72 months

  25. GDMT Score

    β-blockers are scored as 0, 1, or 2 points for no use, use at <50% of the target dose, or use at ≥50% of the target dose, respectively. For renin-angiotensin system inhibitors, no use is scored as 0 points; ACEI/ARB therapy at <50% or ≥50% of the target dose is scored as 1 or 2 points, respectively; and ARNI therapy at any dose is scored as 3 points. Mineralocorticoid receptor antagonists and SGLT2 inhibitors are each scored as 0 points when not used and 2 points when used at any dose. Ivabradine and vericiguat are each scored as 0 points when not used and 1 point when used at any dose. The scores for all medication classes are summed to obtain the total GDMT score, with a higher score indicating a greater degree of GDMT implementation. Target doses are determined according to the relevant heart failure guidelines.

    Measured: Baseline to 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start26 Jul 2026
  3. Primary completion30 Dec 2032 (estimated)
  4. Study completion30 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
942 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07492524
Sponsor's protocol ID
LSKY 2025-192-01,2026-SR-177
Status last verified
Oct 2026
First submitted
16 Mar 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39553909
  • 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.

    PubMed 39984634
  • 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.

    PubMed 41817526

Questions about this trial

What is this clinical trial studying?

A study testing Village-Doctor Led Integrated Care in people with Atrial Fibrillation and Heart Failure, run by Jiangsu Taizhou People's Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ming Chu (13814010410, chuming@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome of Phase 1: Change in MAGGIC Heart Failure Risk Score (time frame: Baseline to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07492524, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in