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

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

Conditions

• COPD (Chronic Obstructive Pulmonary Disease)
• Cardiovascular Disease

Interventions

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.

OTHER

Standard 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 & Collaborators

• University of Bari Aldo Moro

  lead OTHER

Principal Investigators

• Giovanna Elisiana Carpagnano, MD, PhD · Institute of Respiratory Disease, Department of Translational Biomedicine and neuroscience, University "Aldo Moro", Bari, Italy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

41 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2029-04-30

Completion

2029-11-30