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
Qualifiers
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
Treatments tested in this trial
- Structured combined cardio-pulmonary clinical management strategy
- Standard Respiratory Management