Impact of Combined Cardio-pulmonary Assessment on COPD Clinical Management.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age41+
SponsorUniversity of Bari Aldo Moro
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Post-bronchodilator FEV1 ≥ 50% or FEV1 z ≥ -2.5
Age > 40 years
Very high cardiovascular risk
Patients < 50 years old > 7.5%
Disqualifiers
Post-bronchodilator FEV1 < 50% or FEV1 z < -2.5
LTOLT
Active neoplasm
Patient unable to perform lung function
Trial design
Design model
Parallel
Treatments tested in this trial
Structured combined cardio-pulmonary clinical management strategy
Other interventionThis 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.
Standard Respiratory Management
Other interventionParticipants 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.
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Standard Respiratory Assessment (SOC)Active comparator 1 intervention
Group B: Combined Cardio-Pulmonary AssessmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
Change in NT-proBNP Levels
Mean change in plasma NT-proBNP levels from baseline to 12 months.
Time frame
Baseline to 12 months4
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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