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

NCT07481825 NA NOT_YET_RECRUITING

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

Details

Lead sponsor	University of Bari Aldo Moro
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	350
Start date	2026-09
Completion	2029-11

Conditions

• COPD (Chronic Obstructive Pulmonary Disease)
• Cardiovascular Disease

Interventions

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

Primary outcomes

• Change in Left Ventricular Ejection Fraction (EF) — Baseline to 12 months
  Mean change in left ventricular ejection fraction measured by transthoracic echocardiography from baseline to 12 months.
• Change in 6-Minute Walk Distance (6MWD) — Baseline to 12 months
  Mean change in 6-minute walk distance measured according to ERS/ATS standards from baseline to 12 months.
• Change in NT-proBNP Levels — Baseline to 12 months
  Mean change in plasma NT-proBNP levels from baseline to 12 months.
• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score — Baseline to 12 months
  Mean change in KCCQ-12 overall summary score from baseline to 12 months.