Clinical trial NCT06909773: The Prevalence, Disease Burden and Prognosis of COPD in Patients With Cardiovascular Diseases
Official title: The Prevalence, Disease Burden and Prognosis of COPD in Patients With Cardiovascular Diseases -A Multi-center, Prospective, Interventional Study (PRECEDE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-04-04
Enrollment: 3000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number and percentage of COPD in subjects with CVD,CHD,AF,CHF.
timeFrame: Baseline
Secondary outcomes:
measure: The hospitalization/readmission rate in subjects with COPD.
timeFrame: Baseline-week12
measure: The hospitalization/readmission rate in CHD, AF and CHF subjects with COPD.
timeFrame: Baseline-week12
measure: Change from baseline in SAQ score in subjects with CHD and COPD.
timeFrame: Baseline,week4,week8,week12
measure: Change from baseline in AFEQT score in subjects with AF and COPD.
timeFrame: Baseline,week4,week8,week12
measure: Change from baseline in KCCQ score in subjects with CHF and COPD.
timeFrame: Baseline,week4,week8,week12
measure: Change from baseline in CAT score in subjects with COPD.
timeFrame: Baseline,week4,week8,week12
measure: Change from baseline in SGRQ score in subjects with COPD.
timeFrame: Baseline,week4,week8,week12
measure: Change from baseline in 6MWD score in subjects with COPD.
timeFrame: Baseline,week4,week8,week12
measure: Change from baseline in pre-dose FEV1 and FVC value
timeFrame: Baseline,week12
measure: Change from baseline in FEV1 and FVC value within 4 hours post-dosing.
timeFrame: Baseline,week12
measure: The rate of AF recurrence in subjects with AF and COPD.
timeFrame: Baseline-week12
measure: Change from baseline in BNP/NT-proBNP value in the subjects with CHF and COPD.
timeFrame: Baseline,week12
measure: Change from baseline in blood lipids value(TC, LDL, HDL and TG) in the subjects with CHD and COPD.
timeFrame: Baseline,week12
measure: Propotion of newly diagnosed COPD patients in subjects with COPD at baseline.
timeFrame: Baseline
measure: Propotion of newly diagnosed COPD patients in CHD, AF and CHF subjects with COPD at baseline.
timeFrame: Baseline
measure: Propotion of subjects at high risk of COPD in subjects with CVD, CHD, AF and CHF at baseline.
timeFrame: Baseline
measure: Propotion of subjects at high risk of COPD diagnosed with COPD in subjects with CVD, CHD, AF and CHF at baseline.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline,week12
Other outcomes:
measure: The exacerbation rate in CVD, CHD, AF and CHF subjects with COPD over 12 weeks.
timeFrame: Baseline-week12
measure: Rate of MACE in CVD, CHD, AF and CHF subjects with COPD over 12 weeks.
timeFrame: Baseline-week12
measure: Rate of differente types of MACE in CVD, CHD, AF and CHF subjects with COPD over 12 weeks.
timeFrame: Baseline-week12
measure: Risk factors for COPD diagnosis in CHD, AF and CHF subjects (analysis scope includes demographics, physiological data, family history, smoking status, age, comorbidities, lung function parameters, biomarkers, etc.)
timeFrame: Baseline
measure: Risk factors for MACE in subjects with CVD and COPD (analysis scope includes baseline characteristics, baseline PROs, drug treatment, non-drug treatment, lung function parameters, biomarkers, etc.)
timeFrame: Baseline
measure: Change(Mean, standard deviation, median, interquartile range, minimum, and maximum values) from baseline in pre-dose and post-dose IOS parameters(Z at 5 Hz [kPa/(L/s)]、R at 5 Hz [kPa/(L/s)]、R at 10 Hz [kPa/(L/s)] and so on) at week 12.
timeFrame: Baseline,week12
measure: Correlation(via Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between change from baseline in pre-dose/post-dose IOS parameters and change from baseline in CAT score at week 12.
timeFrame: Baseline,week12
measure: Correlation(via Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between change from baseline in pre-dose/post-dose IOS parameters and change from baseline in mMRC score at week 12.
timeFrame: Baseline,week12
measure: Correlation(via Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between change from baseline in pre/post-dose spirometry parameters and change from baseline in CAT score at week 12.
timeFrame: Baseline,week12
measure: Correlation(via Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between change from baseline in pre/post-dose spirometry parameters and change from baseline in mMRC score at week 12.
timeFrame: Baseline,week12
Locations:
Study officials:
References: