Atrial FibrillationNCT07492498
A Village Doctor-led Telehealth Supported Trial of Heart Failure Prevention in AF Patients: MIRACLE-AF 2 (Heart Failure Prevention)
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.
Trial 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… 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
- 1,356 participants
- Where
- 3 sitesChina
- Study dates
- 26 Jul 2026to 30 Dec 2033
- 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
- 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.
- 2)Availability of an electrocardiogram confirming atrial fibrillation, or an official diagnosis certificate of atrial fibrillation issued by a specialist.
- 3)Receiving healthcare management from a primary medical institution near the place of residence.
- 4)Able to understand and sign the informed consent form.
Who cannot join
- A documented history of HF, or newly diagnosed HF according to the 2026 ESC Guidelines for the management of heart failure. HF will require current or prior typical symptoms and/or signs attributable to a structural and/or functional cardiac abnormality. Participants with LVEF <50% will be classified as having heart failure with reduced ejection fraction (HFrEF). In participants with LVEF ≥50%, heart failure with preserved ejection fraction (HFpEF) will require objective evidence of cardiac structural and/or functional abnormalities consistent with left ventricular diastolic dysfunction or elevated filling pressures, supported by elevated natriuretic peptide levels. In participants with AF, supportive echocardiographic abnormalities will include left atrial volume index (LAVI) >40 mL/m², E/e' >15, pulmonary artery systolic pressure >35 mmHg, or tricuspid regurgitation velocity >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.
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
- 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
About this study
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.
Read the detailed description
BACKGROUND Atrial fibrillation (AF) is common among older adults and is strongly associated with heart failure (HF), stroke, hospitalization, cardiovascular death, and all-cause mortality. AF and HF interact bidirectionally and may form a self-perpetuating cycle, particularly in older patients. Although the Atrial Fibrillation Better Care (ABC) pathway is recommended to improve the comprehensive management of AF, older adults with AF in rural China remain particularly vulnerable because of limited access to specialist care, inadequate HF screening and risk stratification, suboptimal implementation of guideline-recommended treatment, and insufficient continuity of follow-up. HF is one of the most common and clinically important complications of AF and is strongly associated with adverse prognosis. Therefore, AF management should extend beyond stroke prevention and incorporate earlier identification, prevention, and management of HF. China's rural primary healthcare system relies heavily on village doctors; however, village doctors often have limited clinical resources, standardized training, and access to specialist support, which may hinder the delivery of long-term integrated care for patients with AF who are at risk of developing HF. A telemedicine-supported, village-doctor-led integrated care model incorporating regular follow-up, medication review, cardiovascular risk monitoring, ABC pathway-based AF management, simplified exercise rehabilitation, timely specialist consultation, and structured patient education may therefore improve cardiovascular health and reduce the risk of incident HF in this population.
AIM OF THIS STUDY This cluster randomized study aims to compare village doctor-led integrated care versus usual care in improving cardiovascular health, guideline-based AF management, self-management adherence, clinical outcomes, and prevention of HF among older rural patients with AF in China.
DESIGN This study is a prospective, cluster randomized, open-label, parallel-group clinical trial conducted in rural China. The study aims to enroll older rural residents aged 65 to 80 years with documented AF and without a history or screening evidence of HF or asymptomatic left ventricular dysfunction at baseline. Village clinics in Jiangsu Province will be randomized in a 1:1 ratio to either the intervention group or the control group. Patients in the intervention group will receive telemedicine-supported, village doctor-led integrated care, including monthly follow-up, symptom assessment, vital-sign monitoring, medication adherence support, cardiovascular risk-factor management, ABC pathway-based AF care, simplified home-based exercise rehabilitation education, and remote cardiology consultation when needed. Village doctors will receive standardized training on stroke prevention and anticoagulation, symptom and rate/rhythm management, and management of cardiovascular risk factors and comorbidities. Patients in the control group will receive usual chronic disease management according to the National Basic Public Health Service requirements, including routine follow-up, general health education, medication documentation, and referral when clinically indicated.
- Conditions
- Atrial Fibrillation, Heart Failure
- 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
- Village doctor-led management. At least one follow-up contact per month will be completed at the clinic or at home, including symptom assessment, vital-sign monitoring, medication adherence management, cardiovascular risk-factor control and health guidance.
- Telemedicine specialist support. When symptoms fluctuate, treatment adjustment is difficult or a management problem arises, the village doctor may upload symptoms, ECG recordings, medication information and examination materials through a dedicated telemedicine platform.
- Standardised guideline training. Village doctors will receive training centred on the AF ABC pathway, covering stroke prevention and anticoagulation, better symptom control, cardiovascular risk-factor management, referral criteria and endpoint identification.
- Simplified exercise rehabilitation and lifestyle education. Village doctors will deliver enhanced health education in accordance with the study team's 15 core messages for lifestyle-related management
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome of Phase 1: 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.
Measured: Baseline to 12 months
Primary Outcome of Phase 2: 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.
Measured: Baseline to 36 months
Primary Outcome of Phase 3: New-incident heart-failure diagnosis
(1) HFrEF - symptomatic cardiac dysfunction with LVEF < 50%; (2) HFpEF - symptoms of HF with LVEF ≥ 50% and echocardiographic evidence of structural or functional cardiac abnormalities; or (3) hospitalisation with heart failure as a primary cause.
Measured: Baseline to 48 months
Primary Outcome of Extension Study: 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.
Measured: Baseline to 84 months
Secondary outcomes (23)
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
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
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
ischemic or hemorrhagic Stroke
All strokes: ischemic or hemorrhagic Stroke
Measured: 12 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care
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: 12 month after baseline
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
Ischemic or hemorrhagic Stroke
All strokes: ischemic or hemorrhagic Stroke
Measured: 36 months after baseline
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
Emergency visit due to AF
Emergency visit due to AF
Measured: 36 months after baseline
All-cause mortality
all-cause death
Measured: 36 months after baseline
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
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: 48 months after baseline
Ischemic or hemorrhagic Stroke
All strokes: ischemic or hemorrhagic Stroke
Measured: 48 months after baseline
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: 48 months after baseline
Emergency visit due to AF
Emergency visit due to AF
Measured: 48 months after baseline
All-cause mortality
all-cause death
Measured: 48 months after baseline
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: 48 month after baseline
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: 84 months after baseline
Ischemic or hemorrhagic Stroke
All strokes: ischemic or hemorrhagic Stroke
Measured: 84 months after baseline
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: 84 months after baseline
Emergency visit due to AF
Emergency visit due to AF
Measured: 84 months after baseline
All-cause mortality
all-cause death
Measured: 84 months after baseline
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: 84 month after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start26 Jul 2026
- Primary completion30 Dec 2033 (estimated)
- Study completion30 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Taizhou People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492498
- Sponsor's protocol ID
- LSKY 2025-191-01，2026-SR-221
- 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, 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 41817526Chu 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 39984634Li 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Village Doctor-led Telehealth Supported Trial of Heart Failure Prevention in AF Patients: MIRACLE-AF 2 (Heart Failure Prevention)
- ClinicalTrials.gov ID
- NCT07492498
- Acronym / sponsor ID
- LSKY 2025-191-01，2026-SR-221
- Conditions
- Atrial Fibrillation, Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,356 participants (estimated)
- Lead sponsor
- Jiangsu Taizhou People's HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University
- Study start
- 26 Jul 2026 (actual)
- Primary completion
- 30 Dec 2033 (estimated)
- Study completion
- 30 Dec 2033 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND Atrial fibrillation (AF) is common among older adults and is strongly associated with heart failure (HF), stroke, hospitalization, cardiovascular death, and all-cause mortality. AF and HF interact bidirectionally and may form a self-perpetuating cycle, particularly in older patients. Although the Atrial Fibrillation Better Care (ABC) pathway is recommended to improve the comprehensive management of AF, older adults with AF in rural China remain particularly vulnerable because of limited access to specialist care, inadequate HF screening and risk stratification, suboptimal implementation of guideline-recommended treatment, and insufficient continuity of follow-up. HF is one of the most common and clinically important complications of AF and is strongly associated with adverse prognosis. Therefore, AF management should extend beyond stroke prevention and incorporate earlier identification, prevention, and management of HF. China's rural primary healthcare system relies heavily on village doctors; however, village doctors often have limited clinical resources, standardized training, and access to specialist support, which may hinder the delivery of long-term integrated care for patients with AF who are at risk of developing HF. A telemedicine-supported, village-doctor-led integrated care model incorporating regular follow-up, medication review, cardiovascular risk monitoring, ABC pathway-based AF management, simplified exercise rehabilitation, timely specialist consultation, and structured patient education may therefore improve cardiovascular health and reduce the risk of incident HF in this population.
AIM OF THIS STUDY This cluster randomized study aims to compare village doctor-led integrated care versus usual care in improving cardiovascular health, guideline-based AF management, self-management adherence, clinical outcomes, and prevention of HF among older rural patients with AF in China.
DESIGN This study is a prospective, cluster randomized, open-label, parallel-group clinical trial conducted in rural China. The study aims to enroll older rural residents aged 65 to 80 years with documented AF and without a history or screening evidence of HF or asymptomatic left ventricular dysfunction at baseline. Village clinics in Jiangsu Province will be randomized in a 1:1 ratio to either the intervention group or the control group. Patients in the intervention group will receive telemedicine-supported, village doctor-led integrated care, including monthly follow-up, symptom assessment, vital-sign monitoring, medication adherence support, cardiovascular risk-factor management, ABC pathway-based AF care, simplified home-based exercise rehabilitation education, and remote cardiology consultation when needed. Village doctors will receive standardized training on stroke prevention and anticoagulation, symptom and rate/rhythm management, and management of cardiovascular risk factors and comorbidities. Patients in the control group will receive usual chronic disease management according to the National Basic Public Health Service requirements, including routine follow-up, general health education, medication documentation, and referral when clinically indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Village-Doctor Led Integrated CareThe 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. |
| Control Group | Active comparator | Other: Usual CareParticipants in this arm will receive usual chronic disease management according to the National Basic Public Health Service requirements. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
- 2)Availability of an electrocardiogram confirming atrial fibrillation, or an official diagnosis certificate of atrial fibrillation issued by a specialist.
- 3)Receiving healthcare management from a primary medical institution near the place of residence.
- 4)Able to understand and sign the informed consent form.
Key exclusion criteria (7 listed)
- A documented history of HF, or newly diagnosed HF according to the 2026 ESC Guidelines for the management of heart failure. HF will require current or prior typical symptoms and/or signs attributable to a structural and/or functional cardiac abnormality. Participants with LVEF <50% will be classified as having heart failure with reduced ejection fraction (HFrEF). In participants with LVEF ≥50%, heart failure with preserved ejection fraction (HFpEF) will require objective evidence of cardiac structural and/or functional abnormalities consistent with left ventricular diastolic dysfunction or elevated filling pressures, supported by elevated natriuretic peptide levels. In participants with AF, supportive echocardiographic abnormalities will include left atrial volume index (LAVI) >40 mL/m², E/e' >15, pulmonary artery systolic pressure >35 mmHg, or tricuspid regurgitation velocity >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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Village-Doctor Led Integrated Care1. Village doctor-led management. At least one follow-up contact per month will be completed at the clinic or at home, including symptom assessment, vital-sign monitoring, medication adherence management, cardiovascular risk-factor control and health guidance. 2. Telemedicine specialist support. When symptoms fluctuate, treatment adjustment is difficult or a management problem arises, the village doctor may upload symptoms, ECG recordings, medication information and examination materials through a dedicated telemedicine platform. 3. Standardised guideline training. Village doctors will receive training centred on the AF ABC pathway, covering stroke prevention and anticoagulation, better symptom control, cardiovascular risk-factor management, referral criteria and endpoint identification. 4. Simplified exercise rehabilitation and lifestyle education. Village doctors will deliver enhanced health education in accordance with the study team's 15 core messages for lifestyle-related management | Other | Intervention Group |
| Usual CareParticipants 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. | Other | Control Group |
Primary outcome
Primary Outcome of Phase 1: Change in Life's Essential 8 Cardiovascular Health Score
Time frame: Baseline to 12 months
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.
Primary Outcome of Phase 2: Composite Cardiovascular Outcome
Time frame: Baseline to 36 months
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.
Primary Outcome of Phase 3: New-incident heart-failure diagnosis
Time frame: Baseline to 48 months
(1) HFrEF - symptomatic cardiac dysfunction with LVEF < 50%; (2) HFpEF - symptoms of HF with LVEF ≥ 50% and echocardiographic evidence of structural or functional cardiac abnormalities; or (3) hospitalisation with heart failure as a primary cause.
Primary Outcome of Extension Study: Composite cardiovascular outcome
Time frame: Baseline to 84 months
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.
23 secondary outcomes
Cardiovascular Death
Time frame: 12 months after baseline
Cardiovascular Hospitalization
Time frame: 12 months after baseline
Emergency Visit for Cardiovascular Events
Time frame: 12 months after baseline
ischemic or hemorrhagic Stroke
Time frame: 12 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care
Time frame: 12 month after baseline
Cardiovascular Death
Time frame: 36 months after baseline
Ischemic or hemorrhagic Stroke
Time frame: 36 months after baseline
Worsening of heart failure or acute coronary syndrome
Time frame: 36 months after baseline
Emergency visit due to AF
Time frame: 36 months after baseline
All-cause mortality
Time frame: 36 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway
Time frame: 36 month after baseline
Cardiovascular Death
Time frame: 48 months after baseline
Ischemic or hemorrhagic Stroke
Time frame: 48 months after baseline
Worsening of heart failure or acute coronary syndrome
Time frame: 48 months after baseline
Emergency visit due to AF
Time frame: 48 months after baseline
All-cause mortality
Time frame: 48 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway
Time frame: 48 month after baseline
Cardiovascular Death
Time frame: 84 months after baseline
Ischemic or hemorrhagic Stroke
Time frame: 84 months after baseline
Worsening of heart failure or acute coronary syndrome
Time frame: 84 months after baseline
Emergency visit due to AF
Time frame: 84 months after baseline
All-cause mortality
Time frame: 84 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway
Time frame: 84 month after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 41817526Li 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.
- Background: PubMed 39984634Chu 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.
- Background: PubMed 39553909Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
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 4 inclusion and 7 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 Life's Essential 8 Cardiovascular Health Score (time frame: Baseline to 12 months). The study lists 4 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 NCT07492498, 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; AzTrials last refreshed its copy on 8 Nov 2026.