The Prevalence of COPD in Patients With Cardiovascular Disease and the Benefit of Cardiopulmonary Co-management

Official title

The Prevalence of COPD in Patients With Cardiovascular Disease and the Benefit of Cardiopulmonary Co-management -A Multi-center, Prospective, Interventional Study (PRECEDE)

Overview

This is a multi-center, prospective, and interventional study conducted in 3 types of cardiovascular diseases (CVD) participants , 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 participants 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 participants with CVD and COPD.

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

Interventions

• Behavioral Guideline education and implementation intervention
  The intervention is implemented at the investigator level and the patient level, consisted of 3 parts： 1. Disease education * Investigator level:All investigators will receive COPD and CVD disease education according to Chinese Guideline pproximately 4 weeks before the first subject is enrolled. * Patient level:After the subjects are enrolled, the cardiologists and pulmonologist will provide disease education on their respective disease areas,education will be provided every 4 weeks unti

Primary outcome measures

• The number and percentage of COPD in participants with CVD,CHD,AF,CHF. [Time frame: Baseline]

Secondary outcome measures (12)

• The hospitalization/readmission rate in participants with COPD. [Time frame: Baseline-week12]
• The hospitalization/readmission rate in CHD, AF and CHF participants with COPD. [Time frame: Baseline-week12]
• Change from baseline in SAQ score in participants with CHD and COPD. [Time frame: Baseline,week4,week8,week12]
• Change from baseline in AFEQT score in participants with AF and COPD. [Time frame: Baseline,week4,week8,week12]
• Change from baseline in KCCQ score in participants with CHF and COPD. [Time frame: Baseline,week4,week8,week12]
• Change from baseline in CAT score in participants with COPD. [Time frame: Baseline,week4,week8,week12]
• Change from baseline in SGRQ score in participants with COPD. [Time frame: Baseline,week4,week8,week12]
• Change from baseline in 6MWD score in participants with COPD. [Time frame: Baseline,week4,week8,week12]
• Change from baseline in pre-dose FEV1 and FVC value [Time frame: Baseline,week12]
• Change from baseline in FEV1 and FVC value within 4 hours post-dosing. [Time frame: Baseline,week12]
• The rate of AF recurrence in participants with AF and COPD. [Time frame: Baseline-week12]
• Change from baseline in BNP/NT-proBNP value in the participants with CHF and COPD. [Time frame: Baseline,week12]

Eligibility criteria

Inclusion criteria

• Give signed written informed consent to participate.
• At least 40 years of age at baseline visit.
• 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 )
• Participants can undergo spirometry testing and does not have the following serious diseases or disease states：

• Shock within the last 3 months
• Mycardial infarction, stroke or unstable angina within last 1 month
• Currently suffering from severe HF or severe arrhythmia. Severe HF refers to the need for intravenous administration of vasoactive drugs and diuretics; severe arrhythmia refers to arrhythmias that cause hemodynamic instability, such as ventricular fibrillation and ventricular tachycardia
• Severe hemoptysis or active gastrointestinal bleeding within last 1 month
• Patients with seizures requiring medication
• Patients with hypertensive crisis or uncontrolled hypertension \[systolic blood pressure > 200 mmHg, diastolic blood pressure > 100 mmHg (1 mmHg = 0.133 kPa)\]
• Patients with active respiratory infectious diseases or infectious diseases, such as open pulmonary tuberculosis, influenza, new coronavirus infection, and acute pneumonia
• Patients with aortic or cerebral aneurysms
• Pneumothorax and pneumothorax healing within last 1 month
• Patients with severe hyperthyroidism
• Patients who have recently had eye, ear, cranial or thoracic or abdominal surgery Note: If the patient can cooperate by completing a single, effective forced exhalation (≥6 seconds), then spirometry testing can be performed.
• Subjects have the cognitive ability to conduct questionnaires after e valuated by investigators.

Exclusion criteria

• Significant diseases or conditions, which, in the opinion of the investigator, may put the participant at risk because of participation in the study or may influence either the results of the study or the participant's ability to participate in the study.
• 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.
• Participant who are not able to provide written informed consent.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

China · 85 centers

• Research Site — Anqing
• Research Site — Beijing
• Research Site — Beijing
• Research Site — Beijing
• Research Site — Beijing
• Research Site — Beijing
• Research Site — Changsha
• Research Site — Changsha
• … and 77 more centers

Identifiers

NCT: NCT06909773 · D2287L00041

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗