NCT07481825Not yet recruiting
Impact of Combined Cardio-pulmonary Assessment on COPD Clinical Management.
Impact of Combined cARdio-pUlmonary aSsessment on COPD Clinical Management: the ICARUS Study
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 15 Mar 2026
- Start date
- Sept 2026
- Primary completion date
- Apr 2029
- Lead sponsor
- University of Bari Aldo Moro
- Diseases
- COPD
- NCT number
- NCT07481825
What you commit to
- Study type: Interventional
- Planned participants: 350
- From Sept 2026 to the primary completion date, Apr 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Post-bronchodilator FEV1 \< 50% or FEV1 z \< -2.5
- LTOLT
- Active neoplasm
- Patient unable to perform lung function
- Pregnancy
Who the study is looking for
- 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)
Age in the registry: 41 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.