Atrial Fibrillation (AF)NCT07611084
Construction of a Cohort of Elderly Patients With Atrial Fibrillation in Rural China
An observational study of Atrial Fibrillation (AF) and Heart Failure, run by Jiangsu Taizhou People's Hospital at 1 site in China.
Trial summary
Atrial fibrillation (AF) is a common arrhythmia in aging populations and is strongly associated with an increased risk of heart failure (HF) and adverse cardiovascular outcomes. However, early detection of HF among patients with AF remain inadequate in rural settings. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF), Heart Failure, Screening
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2026to 31 Dec 2029
- Phase
- Observational
- 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
Study population: The study population is rural-dwelling older adults aged 65 to 80 years with confirmed atrial fibrillation in China. Participants are required to undergo heart failure screening and provide informed consent. Individuals with severe comorbidities or conditions that may interfere with study participation will be excluded.
Who may be able to join
- Permanent residents with local household registration in rural China.
- Aged 65-80 years.
- Electrocardiogram confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist.
- Willing to participate in HF screening.
- 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 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.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology
Taizhou, Jiangsu, 225300
Jun Ye, +86 13625171902, m13625171902@163.com
Ming Chu, Dr.
About this study
Atrial fibrillation (AF) is a common arrhythmia in aging populations and is strongly associated with an increased risk of heart failure (HF) and adverse cardiovascular outcomes. However, early detection of HF among patients with AF remain inadequate in rural settings. This study aims to screen for HF among older adults with AF in rural China and to conduct long-term follow-up in order to observe the disease progression in patients with AF.
This study will recruit at least 2,500 elderly individuals aged between 65 and 80 years, with confirmed diagnoses of AF, residing in rural areas. Participants will undergo HF screening using NT-proBNP testing and echocardiographic assessment. Additionally, data will be collected on electrocardiographic signals, seismocardiography, voice, and demographic characteristics. Following data collection, participants will be followed up every three months to monitor the incidence and progression of HF as well as the occurrence of adverse cardiovascular events.
- Conditions
- Atrial Fibrillation (AF), Heart Failure, Screening, Progression
- Medical subject headings
- Atrial Fibrillation, Heart Failure, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint
a composite of cardiovascular mortality, all strokes (ischemic or hemorrhagic stroke), hospitalization due to worsening of HF or acute coronary syndrome (ACS), and emergency visits due to AF
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start14 Mar 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Taizhou People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Chu, Jiangsu Taizhou People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611084
- Sponsor's protocol ID
- LSKY 2026-016-01
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including baseline characteristics, laboratory results, echocardiographic data, and follow-up outcomes, will be made available upon reasonable request. Data sharing will be subject to approval by the study investigators and in accordance with institutional policies and ethical regulations.
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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Cohort of Elderly Patients With Atrial Fibrillation in Rural China
- ClinicalTrials.gov ID
- NCT07611084
- Acronym / sponsor ID
- LSKY 2026-016-01
- Conditions
- Atrial Fibrillation (AF), Heart Failure, Screening, Progression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Jiangsu Taizhou People's HospitalUniversity, hospital or other
- Study start
- 14 Mar 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 May 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.
Atrial fibrillation (AF) is a common arrhythmia in aging populations and is strongly associated with an increased risk of heart failure (HF) and adverse cardiovascular outcomes. However, early detection of HF among patients with AF remain inadequate in rural settings. This study aims to screen for HF among older adults with AF in rural China and to conduct long-term follow-up in order to observe the disease progression in patients with AF.
This study will recruit at least 2,500 elderly individuals aged between 65 and 80 years, with confirmed diagnoses of AF, residing in rural areas. Participants will undergo HF screening using NT-proBNP testing and echocardiographic assessment. Additionally, data will be collected on electrocardiographic signals, seismocardiography, voice, and demographic characteristics. Following data collection, participants will be followed up every three months to monitor the incidence and progression of HF as well as the occurrence of adverse cardiovascular events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population is rural-dwelling older adults aged 65 to 80 years with confirmed atrial fibrillation in China. Participants are required to undergo heart failure screening and provide informed consent. Individuals with severe comorbidities or conditions that may interfere with study participation will be excluded.
Key inclusion criteria (5 listed)
- Permanent residents with local household registration in rural China.
- Aged 65-80 years.
- Electrocardiogram confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist.
- Willing to participate in HF screening.
- 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 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.
Primary outcome
Composite endpoint
Time frame: through study completion, an average of 3 years
a composite of cardiovascular mortality, all strokes (ischemic or hemorrhagic stroke), hospitalization due to worsening of HF or acute coronary syndrome (ACS), and emergency visits due to AF
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 28 May 2026.
- 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including baseline characteristics, laboratory results, echocardiographic data, and follow-up outcomes, will be made available upon reasonable request. Data sharing will be subject to approval by the study investigators and in accordance with institutional policies and ethical regulations.
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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?
An observational study of 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 5 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 28 May 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 Chuanmeng Zhang, Dr. (+8615996000626, tzyyzcm@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint (time frame: through study completion, an average of 3 years). 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 NCT07611084, 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 28 May 2026.