Cardiovascular Disease, COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Cardiovascular, cardio-pulmonary
Brief summary
The goal of this randomized clinical trial is to learn whether a combined cardio-pulmonary assessment improves cardiac function, exercise capacity, cardiac biomarkers and health-related quality of life in adults with mild-to-moderate chronic obstructive pulmonary disease (COPD) who are at high cardiovascular risk or have established cardiovascular disease. The main questions it aims to answer are: * Does the combined cardio-pulmonary assessment improve mean left ventricular ejection fraction (EF) over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment improve mean 6-minute walk distance (6MWD) over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment reduce mean NT-proBNP over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment improve mean Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score over 12 months compared with standard respiratory care? Researchers will compare a combined cardio-pulmonary assessment to standard respiratory care to see whether the integrated approach leads to greater improvements in EF, 6MWD, NT-proBNP, and KCCQ-12. Participants will: * Be randomly assigned to receive either a combined cardio-pulmonary assessment or standard respiratory care * Complete a baseline visit that includes clinical assessment, respiratory function testing, blood tests (including NT-proBNP), a 6-minute walk test, and the KCCQ-12 questionnaire * Undergo cardiovascular evaluation (electrocardiogram and transthoracic echocardiography) if assigned to the combined assessment group * Attend follow-up evaluation at 12 months, repeating the same assessments according to their assigned group
Interventions
OTHERStructured combined cardio-pulmonary clinical management strategy
This intervention consists of a structured combined cardio-pulmonary outpatient evaluation in patients with COPD and either high cardiovascular risk or established cardiovascular disease. In addition to standard respiratory assessment (clinical history, lung function testing, 6-minute walk test, laboratory tests and guideline-based management), participants undergo a structured cardiovascular evaluation including ECG and transthoracic echocardiography. Treatment optimization is performed according to current respiratory and cardiovascular guidelines based on integrated multidisciplinary assessment. Follow-up is conducted at 12 months using the same integrated approach.
OTHERStandard Respiratory Management
Participants receive standard COPD outpatient evaluation including clinical history, symptom assessment (CAT, mMRC), lung function testing, 6-minute walk test, laboratory testing and guideline-based respiratory management. No structured cardiovascular assessment (ECG or echocardiography) is systematically performed as part of the study intervention. Cardiovascular referral may occur only according to usual clinical practice.
Sponsors
University of Bari Aldo Moro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
41 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients enrolled in the study should be diagnosed as COPD according to international recommendations (1) with the following features: * Post-bronchodilator FEV1 ≥ 50% or FEV1 z ≥ -2.5 * Age \> 40 years Additionally, enrolled patients must fulfill at least one of the following cardiovascular criteria: * Very high cardiovascular risk * according to SCORE2 (12)for patient \< 70 years old and defined as follows: * Patients \< 50 years old \> 7.5% * Patients 50-69 years old \> 10% * according to SCORE OP 2 (13) calculator for patients \> 70 years old and defined as \> 15% * History of ischemic heart disease * Chronic or transient atrial fibrillation * Chronic heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (EF \> 40%) (14)
Exclusion criteria
* Post-bronchodilator FEV1 \< 50% or FEV1 z \< -2.5 * LTOLT * Active neoplasm * Patient unable to perform lung function * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular Ejection Fraction (EF) | Baseline to 12 months | Mean change in left ventricular ejection fraction measured by transthoracic echocardiography from baseline to 12 months. |
| Change in 6-Minute Walk Distance (6MWD) | Baseline to 12 months | Mean change in 6-minute walk distance measured according to ERS/ATS standards from baseline to 12 months. |
| Change in NT-proBNP Levels | Baseline to 12 months | Mean change in plasma NT-proBNP levels from baseline to 12 months. |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score | Baseline to 12 months | Mean change in KCCQ-12 overall summary score from baseline to 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of new cardiovascular diseases diagnoses | Up to 12 months | Number of new cardiovascular disease diagnoses (heart failure, atrial fibrillation, coronary artery disease, systemic arterial hypertension) identified during follow-up. |
| Annual COPD Exacerbation Rate | 12 months | Rate of COPD exacerbations during follow-up (events per patient-year), defined according to standard clinical criteria and recorded from clinical visits/medical records. |
| Change in Forced Expiratory Volume in 1 Second (FEV1) | Baseline to 12 months | Mean change in post-bronchodilator FEV1 from baseline to 12 months measured by spirometry. |
| Emergency department visits or hospitalizations for cardiovascular worsening | Up to 12 months | Number of emergency department visits and/or hospitalizations due to cardiovascular disease worsening during follow-up. |
| Proportion of participants achieving KCCQ-12 MCID improvement | Baseline to 12 months | Number (proportion) of participants with KCCQ-12 improvement above the minimal clinically important difference (MCID): ≥7 points for HFpEF and ≥9 points for HFmrEF. |
Contacts
CONTACTGiovanna Elisiana Carpagnano, MD, PhD
STUDY_DIRECTORGiovanna Elisiana Carpagnano, MD, PhD
Institute of Respiratory Disease, Department of Translational Biomedicine and neuroscience, University "Aldo Moro", Bari, Italy
Outcome results
None listed