COPDNCT07344285
A Prospective Study of Cardiovascular Risk of Patients Admitted for Acute Exacerbation of COPD
A study testing Intervention Group in people with COPD, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective study to assess the burden of existing or hidden cardiovascular (CV) and renal disease in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in a Hong Kong public hospital setting. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Intervention Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jan 2026to 28 Feb 2029
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥40 years
- Patients hospitalized due to COPD exacerbation.
- Patients diagnosed with COPD, a confirmed COPD diagnosis with a specific FEV1/FVC ratio (<0.70)
- Able to provide informed consent
Who cannot join
- Pregnant subjects
- Inability to give informed consent
- Cancer patient who are on active chemotherapy or on palliative care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin, Hong Kong, 0000
Fanny WS Ko, MD, +852 35053133, fannyko@cuhk.edu.hk
David Hui, MD, +85235053133, dschui@cuhk.edu.hk
About this study
This is a prospective study to assess the burden of existing or hidden cardiovascular (CV) and renal disease in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in a Hong Kong public hospital setting. By implementing a chronic obstructive pulmonary disease (COPD) discharge care bundle with integrated CV/renal screening, the study aims to quantify undiscovered disease prevalence, evaluate risk factors for future exacerbations, and compare re-admission rates against historical controls, ultimately informing integrated cardiopulmonary management strategies.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a major global health concern, characterized by persistent respiratory symptoms and airflow limitation, and it frequently coexists with cardiovascular disease (CVD), which significantly contributes to morbidity and mortality in this population.
This is a prospective study to assess the burden of existing or hidden cardiovascular (CV) and renal disease in patients with acute exacerbation of COPD (AECOPD) in a Hong Kong public hospital setting. By implementing a COPD discharge care bundle with integrated CV/renal screening, the study aims to quantify undiscovered disease prevalence, evaluate risk factors for future exacerbations, and compare re-admission rates against historical controls, ultimately informing integrated cardiopulmonary management strategies.
The objectives and hypotheses are as follows:
Objectives and Hypotheses Primary Objective To describe the prevalence of undiscovered cardiovascular and renal disease burden among patients hospitalized for AECOPD in a Hong Kong public clinical setting.
- Hypothesis: A significant proportion of AECOPD patients will have previously undiagnosed CV or renal diseases identified through proactive screening, highlighting the need for routine assessments.
Secondary Objectives
- To describe the pattern of AECOPD risk factors among COPD patients.
- To describe the hospital re-admission rate after care optimization. • Hypotheses: Patients with identified CV diseases will exhibit higher-risk profiles (e.g., elevated BMI, severe symptoms, frequent prior exacerbations), and the implementation of the care bundle will reduce re-admission rates compared to historical standard care.
Exploratory Objectives
- To describe the hospital re-admission rate after care optimization according to the cause of hospitalization (e.g., COPD exacerbation vs. CV/renal-related causes).
- To describe the change in COPD treatment before and after care optimization. • Hypotheses: Re-admissions will be lower for CV/renal causes post-optimization, and a notable percentage of patients will require medication adjustments, such as escalation of inhaler or cardio-kidney-metabolic medications.
The COPD discharge care bundle includes:
- COPD treatment optimization (per Global Obstructive Lung Disease [GOLD] 14 recommendations).
- CV and renal disease check-up (NT-proBNP, Hba1c, troponin, eGFR, uACR, blood pressure and ECG).
- Early follow-up at weeks 4-8.
- Inhaler technique review and education. Patients with newly screened/diagnosed CV or renal diseases will be managed per routine clinical practice according to the relevant international guidelines, with referrals to cardiologists as needed.
- Conditions
- COPD
- Being tested
- Intervention Group, Usual Care
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupProcedure or surgery
Implementation of a COPD discharge care bundle for multidisciplinary support, providing optimal care for patients following acute exacerbations during hospital discharge.
Usual CareProcedure or surgery
Patient undergoing usual care from historic controls
| Study group | Role | What they receive |
|---|---|---|
| Implementation of the COPD discharge care bundle | Experimental | Prospective recruitment with implementation of the COPD discharge care bundle Receives: Procedure: Intervention Group |
| Historic controls | Other | Historical records of prior acute exacerbation of COPD episodes and management under standard care from the database Receives: Procedure: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients observed to have different high-risk factors for future COPD exacerbation
Percentage of patients observed to have different high-risk factors for future COPD exacerbation
Measured: 12 months
Secondary outcomes (2)
Re-admission rate
Re-admission rate due to COPD/cardiovascular/renal-related causes
Measured: 12 months
Major Adverse Cardiac Events (MACE)
Major Adverse Cardiac Events (MACE), defined as myocardial infarction, stroke, death due to cardiovascular events, heart failure, arrhythmias, target vessel revascularization (e.g., repeat angioplasty), unscheduled coronary revascularization and cardiac arrest, will also be assessed.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start15 Jan 2026
- Primary completion16 Jan 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with identified CV diseases will exhibit higher-risk profiles (e.g., elevated BMI, severe symptoms, frequent prior exacerbations), and the implementation of the care bundle will reduce re-admission rates compared to historical standard care
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fanny W.S. Ko, Chinese University of Hong Kong
- Investigators
- David SC Hui, MD, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344285
- Sponsor's protocol ID
- CUHK_Resp_2026_Ko_01
- Status last verified
- Oct 2026
- First submitted
- 7 Jan 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing is available to qualified investigators upon reasonable request. Interested parties should submit a proposal outlining the intended use of the data. Requests will be evaluated for scientific merit and alignment with ethical guidelines. Approved data will be transferred through secure, encrypted channels under a formal data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Cardiovascular Risk of Patients Admitted for Acute Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT07344285
- Acronym / sponsor ID
- CUHK_Resp_2026_Ko_01
- Conditions
- COPD
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 16 Jan 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 15 Jan 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 is a prospective study to assess the burden of existing or hidden cardiovascular (CV) and renal disease in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in a Hong Kong public hospital setting. By implementing a chronic obstructive pulmonary disease (COPD) discharge care bundle with integrated CV/renal screening, the study aims to quantify undiscovered disease prevalence, evaluate risk factors for future exacerbations, and compare re-admission rates against historical controls, ultimately informing integrated cardiopulmonary management strategies.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a major global health concern, characterized by persistent respiratory symptoms and airflow limitation, and it frequently coexists with cardiovascular disease (CVD), which significantly contributes to morbidity and mortality in this population.
This is a prospective study to assess the burden of existing or hidden cardiovascular (CV) and renal disease in patients with acute exacerbation of COPD (AECOPD) in a Hong Kong public hospital setting. By implementing a COPD discharge care bundle with integrated CV/renal screening, the study aims to quantify undiscovered disease prevalence, evaluate risk factors for future exacerbations, and compare re-admission rates against historical controls, ultimately informing integrated cardiopulmonary management strategies.
The objectives and hypotheses are as follows:
Objectives and Hypotheses Primary Objective To describe the prevalence of undiscovered cardiovascular and renal disease burden among patients hospitalized for AECOPD in a Hong Kong public clinical setting.
- Hypothesis: A significant proportion of AECOPD patients will have previously undiagnosed CV or renal diseases identified through proactive screening, highlighting the need for routine assessments.
Secondary Objectives
- To describe the pattern of AECOPD risk factors among COPD patients.
- To describe the hospital re-admission rate after care optimization. • Hypotheses: Patients with identified CV diseases will exhibit higher-risk profiles (e.g., elevated BMI, severe symptoms, frequent prior exacerbations), and the implementation of the care bundle will reduce re-admission rates compared to historical standard care.
Exploratory Objectives
- To describe the hospital re-admission rate after care optimization according to the cause of hospitalization (e.g., COPD exacerbation vs. CV/renal-related causes).
- To describe the change in COPD treatment before and after care optimization. • Hypotheses: Re-admissions will be lower for CV/renal causes post-optimization, and a notable percentage of patients will require medication adjustments, such as escalation of inhaler or cardio-kidney-metabolic medications.
The COPD discharge care bundle includes:
- COPD treatment optimization (per Global Obstructive Lung Disease [GOLD] 14 recommendations).
- CV and renal disease check-up (NT-proBNP, Hba1c, troponin, eGFR, uACR, blood pressure and ECG).
- Early follow-up at weeks 4-8.
- Inhaler technique review and education. Patients with newly screened/diagnosed CV or renal diseases will be managed per routine clinical practice according to the relevant international guidelines, with referrals to cardiologists as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with identified CV diseases will exhibit higher-risk profiles (e.g., elevated BMI, severe symptoms, frequent prior exacerbations), and the implementation of the care bundle will reduce re-admission rates compared to historical standard care
| Arm | Type | Receives |
|---|---|---|
| Implementation of the COPD discharge care bundle | Experimental | Procedure: Intervention GroupProspective recruitment with implementation of the COPD discharge care bundle |
| Historic controls | Other | Procedure: Usual CareHistorical records of prior acute exacerbation of COPD episodes and management under standard care from the database |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥40 years
- Patients hospitalized due to COPD exacerbation.
- Patients diagnosed with COPD, a confirmed COPD diagnosis with a specific FEV1/FVC ratio (<0.70)
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Pregnant subjects
- Inability to give informed consent
- Cancer patient who are on active chemotherapy or on palliative care
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 |
|---|---|---|
| Intervention GroupImplementation of a COPD discharge care bundle for multidisciplinary support, providing optimal care for patients following acute exacerbations during hospital discharge. | Procedure or surgery | Implementation of the COPD discharge care bundle |
| Usual CarePatient undergoing usual care from historic controls | Procedure or surgery | Historic controls |
Primary outcome
Percentage of patients observed to have different high-risk factors for future COPD exacerbation
Time frame: 12 months
Percentage of patients observed to have different high-risk factors for future COPD exacerbation
2 secondary outcomes
Re-admission rate
Time frame: 12 months
Major Adverse Cardiac Events (MACE)
Time frame: 12 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 21 Oct 2026.
- Individual participant dataSharing planned: Yes. Data sharing is available to qualified investigators upon reasonable request. Interested parties should submit a proposal outlining the intended use of the data. Requests will be evaluated for scientific merit and alignment with ethical guidelines. Approved data will be transferred through secure, encrypted channels under a formal data-sharing agreement.
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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.
David SC Hui, MD study director
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with COPD, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 21 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 Hong Kong. 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 Fanny WS Ko, MD (85235053133, fannyko@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients observed to have different high-risk factors for future COPD exacerbation (time frame: 12 months). 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 21 Oct 2026.