Atrial Fibrillation (AF)NCT07896863
Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care for Atrial Fibrillation and Heart Failure Comorbidity in Rural China (MOVE-AF HF)
A study testing Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care Group and Routine Management Group in people with Atrial Fibrillation (AF) and Heart Failure, run by Jiangsu Taizhou People's Hospital at 1 site in China.
Trial summary
AF and HF frequently coexist and are associated with poor clinical outcomes. In rural areas, limited access to echocardiography, NT-proBNP testing, and specialist care may hinder the early identification and appropriate management of HF among patients with AF. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Heart Failure
- What is being tested?
- Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care Group and Routine Management Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2026to 30 Jun 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Permanent residents with local household registration at the primary level in Donghai County, aged ≥ 65 years;
- Electrocardiogram (ECG) confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist;
- Management by a village clinic near the participant's place of residence;
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- Expected life expectancy of less than 3 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
AF and HF frequently coexist and are associated with poor clinical outcomes. In rural areas, limited access to echocardiography, NT-proBNP testing, and specialist care may hinder the early identification and appropriate management of HF among patients with AF. Mobile clinics may help overcome these barriers by bringing diagnostic testing and specialist support directly to rural communities.
This cluster-randomized controlled trial aims to evaluate a mobile clinic-supported, village doctor-led model for HF screening and integrated management among older patients with AF in rural China. Mobile clinics equipped with echocardiography and NT-proBNP testing will support HF screening, and subsequent management will be tailored according to HF status. The study will evaluate whether this model can improve the detection of HF and reduce adverse cardiovascular events compared with routine management.
Read the detailed description
AF and HF frequently coexist and are associated with poor clinical outcomes. In rural areas, limited access to echocardiography, NT-proBNP testing, and specialist care may hinder the early identification and appropriate management of HF among patients with AF. Mobile clinics may help overcome these barriers by bringing diagnostic testing and specialist support directly to rural communities.
This is an open-label, cluster-randomized, parallel-group controlled trial conducted in rural village clinics in Donghai County, Jiangsu Province, China. Village clinics will be randomized in a 1:1 ratio to either a mobile clinic-supported, village doctor-led integrated management group or a routine management group.
In the intervention group, mobile clinics equipped with echocardiography and NT-proBNP testing will provide HF screening. Based on HF status, village doctors and specialists will provide stratified management, including AF management based on the ABC pathway and optimization of guideline-directed medical therapy for HF when appropriate. The control group will receive routine management according to the National Basic Public Health Service standards.
The study will evaluate the rate of newly detected HF at 6 months and a composite cardiovascular outcome at 18 months, including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening HF or acute coronary syndrome, and AF-related emergency department visits.
- Conditions
- Atrial Fibrillation (AF), Heart Failure
- Being tested
- Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care Group, Routine Management Group
- 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.
Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care GroupBehavioural
The intervention consists of mobile clinic-supported HF screening and village doctor-led integrated management for patients with AF. Mobile clinics equipped with echocardiography and NT-proBNP testing will provide HF screening. Management will be stratified according to HF status. Patients without HF will receive integrated AF management based on the ABC pathway, while patients with HF will additionally receive guideline-directed HF management, including optimization of GDMT. Specialists will conduct regular assessments and medication adjustments (once every 3 months), and village doctors will provide ongoing follow-up, medication review, risk-factor management, and health guidance.
Routine Management GroupBehavioural
Participants in the control group will receive routine chronic disease management according to the National Basic Public Health Service standards. Village doctors will provide regular follow-up, general health education, medication documentation, and routine referral services. Participants will continue to receive clinically indicated care but will not receive the mobile clinic-supported HF screening or structured guideline-based management provided to the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care Group | Experimental | Participants in this group will receive mobile clinic-supported, village doctor-led integrated management. Mobile clinics equipped with echocardiography and NT-proBNP testing will provide HF screening for patients with AF. Based on HF status, village doctors and specialists will provide stratified management, including AF management according to the ABC pathway and optimization of guideline-directed medical therapy for HF when appropriate. Specialist-supported mobile clinics will provide regular assessment and medication adjustment (once every 3 months), while village doctors will conduct ongoing follow-up and health management. Receives: Behavioral: Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care Group |
| Routine Management Group | Active comparator | Participants in this group will receive routine chronic disease management according to the National Basic Public Health Service standards. Village doctors will provide regular follow-up, general health education, medication documentation, and routine referral services. Participants will not receive mobile clinic-supported HF screening or the structured guideline-based management provided to the intervention group. Receives: Behavioral: Routine Management Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome of Phase 1: 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: 6 months after baseline
Primary Outcome of Phase 2: Composite Cardiovascular Outcome
The composite outcome includes cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening heart failure or acute coronary syndrome, and emergency department visits due to atrial fibrillation.
Measured: 18 months after baseline
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: 36 months after baseline
Secondary outcomes (9)
The proportion of patients who met all the three criteria for the ABC pathway adherence
Proportion of participants meeting all three 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: 6 months
GDMT medication utilization rate
The proportion of patients who are eligible for guideline-directed medical therapy (GDMT) and actually receive GDMT. 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: 6 months
Incidence and Time to 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: 18 months
Incidence and Time to Ischemic or Hemorrhagic Stroke
All strokes: ischemic or hemorrhagic Stroke
Measured: 18 months
Incidence and Time to Hospitalization for Worsening Heart Failure or Acute Coronary Syndrome
Hospitalization due to worsening heart failure or acute coronary syndrome during follow-up.
Measured: 18 months
Incidence and Time to Emergency visit due to Atrial Fibrillation
Occurrence of an emergency department visit due to atrial fibrillation during follow-up
Measured: 18 months
All-Cause Mortality
Death from any cause during the follow-up period.
Measured: 18 months
The proportion of patients who met all the three criteria for the ABC pathway adherence
Proportion of participants meeting all three 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: 18 months
GDMT medication utilization rate
The proportion of patients who are eligible for guideline-directed medical therapy (GDMT) and actually receive GDMT. 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: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies 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
- None (open label)
- Enrolment
- 1,200 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
- NCT07896863
- Sponsor's protocol ID
- LSKY 2026-134-01
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care for Atrial Fibrillation and Heart Failure Comorbidity in Rural China (MOVE-AF HF)
- ClinicalTrials.gov ID
- NCT07896863
- Acronym / sponsor ID
- LSKY 2026-134-01
- Conditions
- Atrial Fibrillation (AF), Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Jiangsu Taizhou People's HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Oct 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.
AF and HF frequently coexist and are associated with poor clinical outcomes. In rural areas, limited access to echocardiography, NT-proBNP testing, and specialist care may hinder the early identification and appropriate management of HF among patients with AF. Mobile clinics may help overcome these barriers by bringing diagnostic testing and specialist support directly to rural communities.
This cluster-randomized controlled trial aims to evaluate a mobile clinic-supported, village doctor-led model for HF screening and integrated management among older patients with AF in rural China. Mobile clinics equipped with echocardiography and NT-proBNP testing will support HF screening, and subsequent management will be tailored according to HF status. The study will evaluate whether this model can improve the detection of HF and reduce adverse cardiovascular events compared with routine management.
Detailed description
AF and HF frequently coexist and are associated with poor clinical outcomes. In rural areas, limited access to echocardiography, NT-proBNP testing, and specialist care may hinder the early identification and appropriate management of HF among patients with AF. Mobile clinics may help overcome these barriers by bringing diagnostic testing and specialist support directly to rural communities.
This is an open-label, cluster-randomized, parallel-group controlled trial conducted in rural village clinics in Donghai County, Jiangsu Province, China. Village clinics will be randomized in a 1:1 ratio to either a mobile clinic-supported, village doctor-led integrated management group or a routine management group.
In the intervention group, mobile clinics equipped with echocardiography and NT-proBNP testing will provide HF screening. Based on HF status, village doctors and specialists will provide stratified management, including AF management based on the ABC pathway and optimization of guideline-directed medical therapy for HF when appropriate. The control group will receive routine management according to the National Basic Public Health Service standards.
The study will evaluate the rate of newly detected HF at 6 months and a composite cardiovascular outcome at 18 months, including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening HF or acute coronary syndrome, and AF-related emergency department visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care Group | Experimental | Behavioral: Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care GroupParticipants in this group will receive mobile clinic-supported, village doctor-led integrated management. Mobile clinics equipped with echocardiography and NT-proBNP testing will provide HF screening for patients with AF. Based on HF status, village doctors and specialists will provide stratified management, including AF management according to the ABC pathway and optimization of guideline-directed medical therapy for HF when appropriate. Specialist-supported mobile clinics will provide regular assessment and medication adjustment (once every 3 months), while village doctors will conduct ongoing follow-up and health management. |
| Routine Management Group | Active comparator | Behavioral: Routine Management GroupParticipants in this group will receive routine chronic disease management according to the National Basic Public Health Service standards. Village doctors will provide regular follow-up, general health education, medication documentation, and routine referral services. Participants will not receive mobile clinic-supported HF screening or the structured guideline-based management provided to the intervention group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Permanent residents with local household registration at the primary level in Donghai County, aged ≥ 65 years;
- Electrocardiogram (ECG) confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist;
- Management by a village clinic near the participant's place of residence;
- Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria (6 listed)
- Expected life expectancy of less than 3 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.
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 |
|---|---|---|
| Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care GroupThe intervention consists of mobile clinic-supported HF screening and village doctor-led integrated management for patients with AF. Mobile clinics equipped with echocardiography and NT-proBNP testing will provide HF screening. Management will be stratified according to HF status. Patients without HF will receive integrated AF management based on the ABC pathway, while patients with HF will additionally receive guideline-directed HF management, including optimization of GDMT. Specialists will conduct regular assessments and medication adjustments (once every 3 months), and village doctors will provide ongoing follow-up, medication review, risk-factor management, and health guidance. | Behavioural | Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care Group |
| Routine Management GroupParticipants in the control group will receive routine chronic disease management according to the National Basic Public Health Service standards. Village doctors will provide regular follow-up, general health education, medication documentation, and routine referral services. Participants will continue to receive clinically indicated care but will not receive the mobile clinic-supported HF screening or structured guideline-based management provided to the intervention group. | Behavioural | Routine Management Group |
Primary outcome
Primary Outcome of Phase 1: New-incident heart-failure diagnosis
Time frame: 6 months after baseline
(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 Phase 2: Composite Cardiovascular Outcome
Time frame: 18 months after baseline
The composite outcome includes cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening heart failure or acute coronary syndrome, and emergency department visits due to atrial fibrillation.
Primary Outcome of Extension Study: Composite cardiovascular outcome
Time frame: 36 months after baseline
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.
9 secondary outcomes
The proportion of patients who met all the three criteria for the ABC pathway adherence
Time frame: 6 months
GDMT medication utilization rate
Time frame: 6 months
Incidence and Time to Cardiovascular Death
Time frame: 18 months
Incidence and Time to Ischemic or Hemorrhagic Stroke
Time frame: 18 months
Incidence and Time to Hospitalization for Worsening Heart Failure or Acute Coronary Syndrome
Time frame: 18 months
Incidence and Time to Emergency visit due to Atrial Fibrillation
Time frame: 18 months
All-Cause Mortality
Time frame: 18 months
The proportion of patients who met all the three criteria for the ABC pathway adherence
Time frame: 18 months
GDMT medication utilization rate
Time frame: 18 months
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 27 Oct 2026.
- Results publication: 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.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care Group and Routine Management Group in people with Atrial Fibrillation (AF) and Heart Failure, run by Jiangsu Taizhou People's Hospital at 1 site 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 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: opening soon, as of the sponsor's last update on 27 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 1 site 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 Hongmei Zhou (+86 13961325123, 1109873714@qq.com), 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: New-incident heart-failure diagnosis (time frame: 6 months after baseline). 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 NCT07896863, which also lists 1 linked publication.
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 27 Oct 2026.