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

March 15, 2026 updated by: Prof. Giovanna Elisiana Carpagnano, University of Bari Aldo Moro

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Respiratory Assessment (SOC)
Participants receive standard COPD outpatient evaluation including clinical assessment, lung function testing, 6MWT, blood tests, and guideline-based management without structured cardiovascular assessment.
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.
Other Names:
  • Standard of Care (SOC)
Active Comparator: Combined Cardio-Pulmonary Assessment
Participants receive standard COPD outpatient evaluation plus structured cardiovascular assessment including ECG and transthoracic echocardiography, with integrated cardio-pulmonary management.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of new cardiovascular diseases diagnoses
Time Frame: Up to 12 months
Number of new cardiovascular disease diagnoses (heart failure, atrial fibrillation, coronary artery disease, systemic arterial hypertension) identified during follow-up.
Up to 12 months
Annual COPD Exacerbation Rate
Time Frame: 12 months
Rate of COPD exacerbations during follow-up (events per patient-year), defined according to standard clinical criteria and recorded from clinical visits/medical records.
12 months
Change in Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline to 12 months
Mean change in post-bronchodilator FEV1 from baseline to 12 months measured by spirometry.
Baseline to 12 months
Emergency department visits or hospitalizations for cardiovascular worsening
Time Frame: Up to 12 months
Number of emergency department visits and/or hospitalizations due to cardiovascular disease worsening during follow-up.
Up to 12 months
Proportion of participants achieving KCCQ-12 MCID improvement
Time Frame: Baseline to 12 months
Number (proportion) of participants with KCCQ-12 improvement above the minimal clinically important difference (MCID): ≥7 points for HFpEF and ≥9 points for HFmrEF.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari Aldo Moro

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

March 15, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2447/CEL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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