Impact of Combined Cardio-pulmonary Assessment on COPD Clinical Management.

Sponsor
University of Bari Aldo Moro
Study ID
NCT07481825
Status
Not Yet Recruiting

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Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)
  • Cardiovascular Disease

Eligibility Criteria

Sex
ALL
Age
41 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Structured combined cardio-pulmonary clinical management strategy — OTHER
    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.
  • Standard Respiratory Management — OTHER
    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.

Study Details

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

Key Dates

First listed
Mar 19, 2026
Start date
Sep 30, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Respiratory Assessment (SOC)
    Participants receive standard COPD outpatient evaluation including clinical assessment, lung function testing, 6MWT, blood tests, and guideline-based management without structured cardiovascular assessment.
  • Active Comparator: Combined Cardio-Pulmonary Assessment
    Participants receive standard COPD outpatient evaluation plus structured cardiovascular assessment including ECG and transthoracic echocardiography, with integrated cardio-pulmonary management.

Primary Outcome Measure

Change in Left Ventricular Ejection Fraction (EF) [ Time Frame: Baseline to 12 months ]

Central Contacts

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