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

Impact of Combined cARdio-pUlmonary aSsessment on COPD Clinical Management: the ICARUS Study

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

Inclusion Criteria:

Patients enrolled in the study should be diagnosed as COPD according to international recommendations (1) with the following features:

• Post-bronchodilator FEV1 ≥ 50% or FEV1 z ≥ -2.5
• Age > 40 years

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:

    • Patients < 50 years old > 7.5%
    • Patients 50-69 years old > 10%

  • according to SCORE OP 2 (13) calculator for patients > 70 years old and defined as > 15%

• History of ischemic heart disease

• Chronic or transient atrial fibrillation

• Chronic heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (EF > 40%) (14)

Exclusion Criteria:

• Post-bronchodilator FEV1 < 50% or FEV1 z < -2.5
• LTOLT
• Active neoplasm
• Patient unable to perform lung function
• Pregnancy