A Prospective Study of Cardiovascular Risk of Patients Admitted for Acute Exacerbation of COPD

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD
• Intervention / Treatment: Procedure: Intervention Group; Procedure: Usual Care

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

1. To describe the pattern of AECOPD risk factors among COPD patients.
2. 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

1. 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).
2. 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:

1. COPD treatment optimization (per Global Obstructive Lung Disease [GOLD] 14 recommendations).
2. CV and renal disease check-up (NT-proBNP, Hba1c, troponin, eGFR, uACR, blood pressure and ECG).
3. Early follow-up at weeks 4-8.
4. 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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fanny WS Ko, MD; Phone Number: 85235053133; Email: fannyko@cuhk.edu.hk
• Study Contact Backup: Name: David SC Hui, MD; Phone Number: 85235053128; Email: dschui@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnant subjects
• Inability to give informed consent
• Cancer patient who are on active chemotherapy or on palliative care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implementation of the COPD discharge care bundle; Prospective recruitment with implementation of the COPD discharge care bundle	Procedure: Intervention Group; Implementation of a COPD discharge care bundle for multidisciplinary support, providing optimal care for patients following acute exacerbations during hospital discharge.
Other: Historic controls; Historical records of prior acute exacerbation of COPD episodes and management under standard care from the database	Procedure: Usual Care; Patient undergoing usual care from historic controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-admission rate	Re-admission rate due to COPD/cardiovascular/renal-related causes	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.	12 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Study Director: David SC Hui, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): January 16, 2029
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CUHK_Resp_2026_Ko_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: From 17 Jan 2026 to 17 Jan 2046
• IPD Sharing Access Criteria: The principal investigator will access the IPD and supporting information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No