NCT07344285

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Jan 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Jan 2026Feb 2029

First Submitted

Initial submission to the registry

January 7, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2029

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

January 7, 2026

Last Update Submit

January 17, 2026

Conditions

COPD

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Re-admission rate

    12 months

  • Major Adverse Cardiac Events (MACE)

    12 months

Study Arms (2)

Implementation of the COPD discharge care bundle

EXPERIMENTAL

Prospective recruitment with implementation of the COPD discharge care bundle

Procedure: Intervention Group

Historic controls

OTHER

Historical records of prior acute exacerbation of COPD episodes and management under standard care from the database

Procedure: Usual Care

Interventions

Intervention GroupPROCEDURE

Implementation of a COPD discharge care bundle for multidisciplinary support, providing optimal care for patients following acute exacerbations during hospital discharge.

Implementation of the COPD discharge care bundle
Usual CarePROCEDURE

Patient undergoing usual care from historic controls

Historic controls

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David SC Hui, MD

    Chinese University of Hong Kong

    STUDY DIRECTOR

Central Study Contacts

Fanny WS Ko, MD

CONTACT

85235053133fannyko@cuhk.edu.hk

David SC Hui, MD

CONTACT

85235053128dschui@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary clinical professor

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 15, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

January 16, 2029

Study Completion (Estimated)

February 28, 2029

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
From 17 Jan 2026 to 17 Jan 2046
Access Criteria
The principal investigator will access the IPD and supporting information.