An interventional study of Structured combined cardio-pulmonary clinical management strategy and Standard Respiratory Management in COPD (Chronic Obstructive Pulmonary Disease) and Cardiovascular Disease, sponsored by University of Bari Aldo Moro. Not yet recruiting. Open to participants aged 41 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by University of Bari Aldo Moro · Not applicable, Interventional, and Treatment
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:
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:
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 350 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University of Bari Aldo Moro is the lead sponsor of 30 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients enrolled in the study should be diagnosed as according to international recommendations (1) with the following features:
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard COPD outpatient evaluation including clinical assessment, lung function testing, 6MWT, blood tests, and guideline-based management without structured cardiovascular assessment.
Other: Standard Respiratory Management
Participants receive standard COPD outpatient evaluation plus structured cardiovascular assessment including ECG and transthoracic echocardiography, with integrated cardio-pulmonary management.
Other: Structured 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.
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.
Also known as: Standard of Care (SOC)
Change in Left Ventricular Ejection Fraction (EF)
Mean change in left ventricular ejection fraction measured by transthoracic echocardiography from baseline to 12 months.
Time frame: Baseline to 12 months
Change in 6-Minute Walk Distance (6MWD)
Mean change in 6-minute walk distance measured according to ERS/ATS standards from baseline to 12 months.
Time frame: Baseline to 12 months
Change in NT-proBNP Levels
Mean change in plasma NT-proBNP levels from baseline to 12 months.
Time frame: Baseline to 12 months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score
Mean change in KCCQ-12 overall summary score from baseline to 12 months.
Time frame: Baseline to 12 months
Number of new cardiovascular diseases diagnoses
Number of new cardiovascular disease diagnoses (heart failure, atrial fibrillation, coronary artery disease, systemic arterial hypertension) identified during follow-up.
Time frame: Up to 12 months
Annual COPD Exacerbation Rate
Rate of COPD exacerbations during follow-up (events per patient-year), defined according to standard clinical criteria and recorded from clinical visits/medical records.
Time frame: 12 months
Change in Forced Expiratory Volume in 1 Second (FEV1)
Mean change in post-bronchodilator FEV1 from baseline to 12 months measured by spirometry.
Time frame: Baseline to 12 months
Emergency department visits or hospitalizations for cardiovascular worsening
Number of emergency department visits and/or hospitalizations due to cardiovascular disease worsening during follow-up.
Time frame: Up to 12 months
Proportion of participants achieving KCCQ-12 MCID improvement
Number (proportion) of participants with KCCQ-12 improvement above the minimal clinically important difference (MCID): ≥7 points for HFpEF and ≥9 points for HFmrEF.
Time frame: Baseline to 12 months
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
University of Bari Aldo Moro