Atrial Fibrillation (AF)NCT07149688
Village-Based Management of Chronic Cardiovascular Disease in Qu Jiang Elderly Population Registry: The BOUQUET Cohort Study
An observational study of Atrial Fibrillation (AF) and Hypertension, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
This is a prospective observational cohort study conducted in Qujiang District, Zhejiang Province, China, aiming to evaluate the effectiveness of a comprehensive management program for elderly patients with chronic cardiovascular diseases (CVDs). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF), Hypertension, Coronary Heart Disease (CHD)
- What is being tested?
- Comprehensive management program (pharmacologic treatment, lifestyle modification, health education, structured follow-up)
- Type of treatment
- Medical device
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Mar 2035
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-dwelling elderly residents of Qujiang District with chronic cardiovascular diseases.
Who may be able to join
- Age ≥60 years
- Resident of Qujiang District
- Diagnosed with chronic CVD (hypertension, coronary artery disease, heart failure, atrial fibrillation, or others)
- Able and willing to provide informed consent
Who cannot join
- Severe cognitive impairment or inability to provide consent
- Life expectancy <1 year due to non-cardiovascular disease
- Participation refusal
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
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Le Zhou, MD, 010-13840293506, 13840293506@163.com
13840293506@163.com
About this study
This is a prospective observational cohort study conducted in Qujiang District, Zhejiang Province, China, aiming to evaluate the effectiveness of a comprehensive management program for elderly patients with chronic cardiovascular diseases (CVDs). The program integrates pharmacological treatment, lifestyle modification, health education, and long-term follow-up, with enhanced monitoring using 7-day ECG recording. The study focuses on major chronic CVDs including hypertension, coronary artery disease, atrial fibrillation, and heart failure. Approximately 30,000 participants aged ≥60 years will be enrolled and followed for up to 10 years.
Read the detailed description
With the acceleration of global population aging, older adults have become the primary population at high risk for chronic cardiovascular diseases (CVD). Cardiovascular disease is one of the leading causes of mortality and disability worldwide, and its prevalence and associated disability are markedly higher among the elderly compared to younger age groups. According to data from the World Health Organization (WHO), CVD accounts for approximately 31% of global deaths, with older adults carrying a substantial proportion of this burden.
Due to age-related physiological changes, the presence of multiple comorbidities, and lifestyle factors, elderly individuals often face more complex health challenges. In this population, chronic hypertension, coronary artery disease, heart failure, and diabetes are highly prevalent and frequently coexist. These conditions tend to be chronic, progressive, and involve multiple organ systems, further complicating disease management. Moreover, elderly patients often experience poor drug tolerance, multiple complications, and impaired quality of life, which necessitate not only more refined clinical interventions but also individualized management strategies tailored to patient-specific needs.
Traditional single-disease treatment strategies are often insufficient to address the multifaceted needs of elderly patients with chronic cardiovascular diseases. Existing evidence suggests that comprehensive management models-integrating multidisciplinary collaboration, personalized treatment, long-term follow-up, and health education-can significantly improve cardiovascular outcomes, reducing hospitalization rates, mortality, and other adverse events. However, systematic research on comprehensive management in elderly populations remains limited. Most current studies focus on specific diseases or therapeutic approaches, lacking multidimensional assessment and intervention strategies.
Therefore, the present study aims to establish a comprehensive management cohort for chronic cardiovascular diseases in elderly populations, in order to explore how integrated management strategies influence cardiovascular health in real-world settings. This study will evaluate the effectiveness of such approaches in reducing cardiovascular events and mortality, thereby providing scientific evidence and guidance for future clinical practice. The Qujiang Project Team of the National Clinical Research Center for Cardiovascular Diseases will undertake this study.
- Being tested
- Comprehensive management program (pharmacologic treatment, lifestyle modification, health education, structured follow-up)
- Medical subject headings
- Atrial Fibrillation, Hypertension, Coronary Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive management program (pharmacologic treatment, lifestyle modification, health education, structured follow-up)Device
Comprehensive management program (pharmacologic treatment, lifestyle modification, health education, structured follow-up)
Enhanced monitoring with 7-day ECG
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiovascular events
Incidence of cardiovascular events (myocardial infarction, stroke, hospitalization for heart failure, cardiovascular death) - assessed annually during follow-up
Measured: 10 years
All-cause and cardiovascular mortality
All-cause and cardiovascular mortality - assessed at 10 years
Measured: 10 years
Secondary outcomes (2)
Hospitalization rates
Hospitalization rates (number and duration of hospitalizations for CVD-related causes)
Measured: 10 years
Atrial fibrillation burden
Atrial fibrillation burden - time proportion of AF episodes, number of episodes, longest episode duration (measured during 7-day ECG monitoring in the blanking period and annually thereafter)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Mar 2024
- Primary completion1 Mar 2035 (estimated)
- Study completion1 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149688
- Sponsor's protocol ID
- The BOUQUET Cohort Study
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Village-Based Management of Chronic Cardiovascular Disease in Qu Jiang Elderly Population Registry: The BOUQUET Cohort Study
- ClinicalTrials.gov ID
- NCT07149688
- Acronym / sponsor ID
- The BOUQUET Cohort Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2035 (estimated)
- Study completion
- 1 Mar 2035 (estimated)
- First posted
- 2 Sep 2025 (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 is a prospective observational cohort study conducted in Qujiang District, Zhejiang Province, China, aiming to evaluate the effectiveness of a comprehensive management program for elderly patients with chronic cardiovascular diseases (CVDs). The program integrates pharmacological treatment, lifestyle modification, health education, and long-term follow-up, with enhanced monitoring using 7-day ECG recording. The study focuses on major chronic CVDs including hypertension, coronary artery disease, atrial fibrillation, and heart failure. Approximately 30,000 participants aged ≥60 years will be enrolled and followed for up to 10 years.
Detailed description
With the acceleration of global population aging, older adults have become the primary population at high risk for chronic cardiovascular diseases (CVD). Cardiovascular disease is one of the leading causes of mortality and disability worldwide, and its prevalence and associated disability are markedly higher among the elderly compared to younger age groups. According to data from the World Health Organization (WHO), CVD accounts for approximately 31% of global deaths, with older adults carrying a substantial proportion of this burden.
Due to age-related physiological changes, the presence of multiple comorbidities, and lifestyle factors, elderly individuals often face more complex health challenges. In this population, chronic hypertension, coronary artery disease, heart failure, and diabetes are highly prevalent and frequently coexist. These conditions tend to be chronic, progressive, and involve multiple organ systems, further complicating disease management. Moreover, elderly patients often experience poor drug tolerance, multiple complications, and impaired quality of life, which necessitate not only more refined clinical interventions but also individualized management strategies tailored to patient-specific needs.
Traditional single-disease treatment strategies are often insufficient to address the multifaceted needs of elderly patients with chronic cardiovascular diseases. Existing evidence suggests that comprehensive management models-integrating multidisciplinary collaboration, personalized treatment, long-term follow-up, and health education-can significantly improve cardiovascular outcomes, reducing hospitalization rates, mortality, and other adverse events. However, systematic research on comprehensive management in elderly populations remains limited. Most current studies focus on specific diseases or therapeutic approaches, lacking multidimensional assessment and intervention strategies.
Therefore, the present study aims to establish a comprehensive management cohort for chronic cardiovascular diseases in elderly populations, in order to explore how integrated management strategies influence cardiovascular health in real-world settings. This study will evaluate the effectiveness of such approaches in reducing cardiovascular events and mortality, thereby providing scientific evidence and guidance for future clinical practice. The Qujiang Project Team of the National Clinical Research Center for Cardiovascular Diseases will undertake this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling elderly residents of Qujiang District with chronic cardiovascular diseases.
Key inclusion criteria (4 listed)
- Age ≥60 years
- Resident of Qujiang District
- Diagnosed with chronic CVD (hypertension, coronary artery disease, heart failure, atrial fibrillation, or others)
- Able and willing to provide informed consent
Key exclusion criteria (3 listed)
- Severe cognitive impairment or inability to provide consent
- Life expectancy <1 year due to non-cardiovascular disease
- Participation refusal
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 |
|---|---|---|
| Comprehensive management program (pharmacologic treatment, lifestyle modification, health education, structured follow-up)Comprehensive management program (pharmacologic treatment, lifestyle modification, health education, structured follow-up) Enhanced monitoring with 7-day ECG | Device | – |
Primary outcome
Incidence of cardiovascular events
Time frame: 10 years
Incidence of cardiovascular events (myocardial infarction, stroke, hospitalization for heart failure, cardiovascular death) - assessed annually during follow-up
All-cause and cardiovascular mortality
Time frame: 10 years
All-cause and cardiovascular mortality - assessed at 10 years
2 secondary outcomes
Hospitalization rates
Time frame: 10 years
Atrial fibrillation burden
Time frame: 10 years
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 2 Sep 2025.
- 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?
An observational study of Atrial Fibrillation (AF) and Hypertension, run by Beijing Anzhen 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 3 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 2 Sep 2025. 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 Le Zhou, MD (+8613840293506, 13840293506@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiovascular events (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2025.