UMIN-ICDS Clinical Trial

Public title

Cardiovascular diseases in COPD patients with severe acute exacerbations: the prevalence and early identification of undiagnosed cardiac comorbidities- A prospective observational study

Acronym

CVD in COPD exacerbation

Scientific Title

Cardiovascular diseases in COPD patients with severe acute exacerbations: the prevalence and early identification of undiagnosed cardiac comorbidities- A prospective observational study

Scientific Title:Acronym

CVD in COPD with severe exacerbations- the prevalence and early identification

Region

Asia(except Japan)

Condition

Cardiovascular diseases (CVD), including heart failure, ischemic heart disease, arrhythmias, and pulmonary hypertension, are common in patients with COPD and contribute substantially to morbidity and mortality. During acute exacerbations of COPD (AECOPD), cardiovascular events may be overlooked because their symptoms overlap with those of respiratory deterioration. Studies suggest that up to 40% of hospitalized AECOPD patients have unrecognized cardiac comorbidities. However, routine cardiovascular screening is not currently recommended. Exercise-induced desaturation (EID), commonly assessed by the six-minute walk test, is associated with adverse cardiopulmonary outcomes and may serve as a marker of occult cardiovascular dysfunction. Early EID assessment after stabilization of AECOPD may provide a practical approach for identifying previously undiagnosed cardiovascular disease.

Classification by specialty

Cardiology

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This prospective observational study aims to determine the prevalence of coexisting cardiovascular diseases, including newly diagnosed and previously unrecognized conditions, in patients hospitalized with severe AECOPD.

Basic objectives2

Others

Basic objectives -Others

The study also evaluates the utility of a comprehensive proactive cardiac workup during the acute phase and Exercise-induced desaturation (EID) testing in the recovery phase for the early detection of occult cardiac comorbidities and cardiovascular events.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

To evaluate whether a proactive comprehensive cardiac workup at the time of AECOPD is effective in detecting previously undiagnosed cardiac comorbidities and unrecognized concurrent CV events.

Key secondary outcomes

1. To evaluate the clinical value of EID during a spontaneous walking test, conducted in the recovery phase after acute symptom relief to detect undiagnosed cardiac comorbidities and unrecognized CV events.
2. To determine the prevalence of cardiac comorbidities in severe AECOPD patients (including newly diagnosed and existing diseases)
3. To investigate the proportion of coexisting CV events diagnosed by the proactive workup
4. To compare the changes of FeNO levels, symptom scores (CAT, mMRC), blood tests (CRP, CBC/DC, D-dimer), physiological parameters (both cardiac and pulmonary function), and EID among acute, recovery, and follow-up phases
5. To compare the major outcomes (annual rate of AECOPD, CV events, cardiopulmonary events) between baseline and follow-up phases
6. To discover the impact of CV comorbidities on the major outcomes (annual rate of AECOPD, CV events, cardiopulmonary events)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Male or female outpatients aged from 40 to 90 years
2. Spirometry confirmed COPD patients (post-bronchodilation FEV1/FVC < 0.7) with medical record >= 1 year
3. Meet the criteria of severe AECOPD
4. Agree to attend the study and sign informed consent

Key exclusion criteria

1. Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
2. Hemodynamic instability requiring a life support machine, such as ECMO, IABP
3. Respiratory failure requiring intubation and mechanical ventilation
4. Coexisting medical conditions with a life expectancy of less than 1 year
5. Mental problem or unclear consciousness to obey medical treatment
6. Inability to ambulate or perform walking test

Target sample size

104

Name of lead principal investigator

1st name	Kang-Cheng
Middle name
Last name	Su

Organization

Taipei Veterans General Hospital

Division name

Department of Chest Medicine

Zip code

112201

Address

No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City,Taiwan 112201, R.O.C.

TEL

886-2-28712121-3152

Email

kcsu@vghtpe.gov.tw

Name of contact person

1st name	Kang-Cheng
Middle name
Last name	Su

Organization

Taipei Veterans General Hospital

Division name

Department of Chest Medicine

Zip code

112201

Address

No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City,Taiwan 112201, R.O.C.

TEL

886-2-28712121-3152

Homepage URL

Email

kcsu@vghtpe.gov.tw

Institute

Taipei Veterans General Hospital

Institute

Department

Personal name

Organization

Taipei Veterans General Hospital

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Taipei Veterans General Hospital

Address

No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City,Taiwan 112201, R.O.C.

Tel

+886-2-28757384

Email

irbopinion@vghtpe.gov.tw

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

05

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2025

Year

06

Month

20

Day

Date of IRB

2025

Year

08

Month

15

Day

Anticipated trial start date

2026

Year

01

Month

01

Day

Last follow-up date

2026

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This prospective observational study. An estimated 104 spirometry-confirmed COPD patients aged 40-90 years, presenting with severe AECOPD (requiring emergency department visit or hospitalization), will be prospectively enrolled over a 12-month period. Participants will undergo a standardized cardiac assessment protocol that includes electrocardiography, cardiac enzyme and BNP or NT-proBNP testing, D-dimer assay, echocardiography, and EID testing during both the acute and recovery phases. Additional imaging, such as myocardial perfusion scans or coronary angiography, will be performed based on clinical indications. Data will be collected across the acute, recovery, and follow-up phases (up to 48 weeks). Comparative analyses will be conducted between patients with and without cardiovascular comorbidities.

Registered date

2026

Year

05

Month

31

Day

Last modified on

2026

Year

05

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070668