- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07611084
Construction of a Cohort of Elderly Patients With Atrial Fibrillation in Rural China
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 Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chuanmeng Zhang, Dr.
- Phone Number: +8615996000626
- Email: tzyyzcm@njmu.edu.cn
Study Locations
-
-
Jiangsu
-
Taizhou, Jiangsu, China, 225300
- Recruiting
- Department of Cardiology
-
Contact:
- Jun Ye
- Phone Number: +86 13625171902
- Email: m13625171902@163.com
-
Principal Investigator:
- Ming Chu, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
through study completion, an average of 3 years
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSKY 2026-016-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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