The Prevalence, Disease Burden and Prognosis of COPD in Patients With Cardiovascular Diseases

Not Applicable

Not yet recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT06909773
• Lead Sponsor: AstraZeneca

Brief Summary

This is a multi-center, prospective, and interventional study conducted in 3 types of cardiovascular diseases (CVD) subjects , including 3 cohorts which are patients with newly or previously diagnosed coronary heart disease ( CHD), atrial fibrillation ( AF) and chronic heart failure (CHF).

Detailed Description

The mainly purpose of this study is describe the prevalence of COPD of the subjects with 3 types of CVD who are aged 40 years or older, and also observe the effect of cardiopulmonary co management on the short term prognosis of subjects with CVD and COPD.

This study will enroll approximately 3,000 subjects, with approximately 1,000 subjects in each cohort.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Study Start: 2025-05-31
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. Give signed written informed consent to participate.

2. At least 40 years of age at baseline visit.

3. Previous or newly diagnosed by at least one of the 3 types of CVD which are,

   • Coronary heart disease ( CHD )
   • Atrial fibrillation (AF )
   • Chronic heart failure ( CHF )

4. Subjects have no absolute contraindications to spirometry testing.

5. Subjects have the cognitive ability to conduct questionnaires after e valuated by investigators.

Exclusion Criteria

1. Significant diseases or conditions, which, in the opinion of the investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
2. Women who are pregnant or lactating or are planning to become pregnant, or women of childbearing potential who are not using an acceptable method of contraception.
3. Subjects who are not able to provide written informed consent.
4. Treatment with investigational study drug or device in another clinical study within the last 30 days or five half lives prior to baseline visit , whichever is longer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The number and percentage of COPD in subjects with CVD,CHD,AF,CHF.	Baseline	To describe the prevalence of COPD in subjects with CVD.

Secondary Outcome Measures

Name	Time	Method
The hospitalization/readmission rate in subjects with COPD.	Baseline-week12	To describe the hospitalization/readmission rate in subjects with COPD during the implementation of cardiopulmonary co-management.
The hospitalization/readmission rate in CHD, AF and CHF subjects with COPD.	Baseline-week12	To describe the hospitalization/readmission rate in subjects with CVD during the implementation of cardiopulmonary co-management.
Change from baseline in SAQ score in subjects with CHD and COPD.	Baseline,week4,week8,week12	To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in subjects with COPD.
Change from baseline in AFEQT score in subjects with AF and COPD.	Baseline,week4,week8,week12	To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in subjects with COPD.
Change from baseline in KCCQ score in subjects with CHF and COPD.	Baseline,week4,week8,week12	To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in subjects with COPD.
Change from baseline in CAT score in subjects with COPD.	Baseline,week4,week8,week12	To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in subjects with COPD.
Change from baseline in SGRQ score in subjects with COPD.	Baseline,week4,week8,week12	To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in subjects with COPD.
Change from baseline in 6MWD score in subjects with COPD.	Baseline,week4,week8,week12	To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in subjects with COPD.
Change from baseline in pre-dose FEV1 and FVC value	Baseline,week12	To describe the effects of cardiopulmonary co-management on lung function in subjects with COPD.
Change from baseline in FEV1 and FVC value within 4 hours post-dosing.	Baseline,week12	To describe the effects of cardiopulmonary co-management on lung function in subjects with COPD.
The rate of AF recurrence in subjects with AF and COPD.	Baseline-week12	To describe the rate of AF recurrence during the period of cardiopulmonary co-management.
Change from baseline in BNP/NT-proBNP value in the subjects with CHF and COPD.	Baseline,week12	To describe the change of biomarkers in the subjects with CVD and COPD during the period of cardiopulmonary co-management.
Change from baseline in blood lipids value(TC, LDL, HDL and TG) in the subjects with CHD and COPD.	Baseline,week12	To describe the change of biomarkers in the subjects with CVD and COPD during the period of cardiopulmonary co-management.
Propotion of newly diagnosed COPD patients in subjects with COPD at baseline.	Baseline	To describe the undiagnosed rate of COPD in subjects with CVD.
Propotion of newly diagnosed COPD patients in CHD, AF and CHF subjects with COPD at baseline.	Baseline	To describe the undiagnosed rate of COPD in subjects with CVD.
Propotion of subjects at high risk of COPD in subjects with CVD, CHD, AF and CHF at baseline.	Baseline	To describe the proportion of subjects at high risk of COPD among CVD patients.
Propotion of subjects at high risk of COPD diagnosed with COPD in subjects with CVD, CHD, AF and CHF at baseline.	Baseline	To describe the proportion of subjects at high risk of COPD among CVD patients.
Distribution of stable COPD medications by drug class (ICS, ICS/LABA, methylxanthines,etc) and others [antibiotics, systemic corticosteroids, traditional Chinese medicine, etc]) in mono or combination at baseline and week 12.	Baseline,week12	To describe the COPD-related treatment patterns before and after the implementation of cardiopulmonary co-management.