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NCT Number: NCT07481825

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

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

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Cardiovascular Disease Cardiovascular Diseases Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

41 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured combined cardio-pulmonary clinical management strategy

Other

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.

Standard Respiratory Management

Other

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)

Primary outcomes

  1. 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.

  2. 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.

  3. Change in NT-proBNP Levels

    Time frame: Baseline to 12 months

    Mean change in plasma NT-proBNP levels from baseline to 12 months.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanna Elisiana Carpagnano, MD, PhD

CONTACT

[email protected]

+39 080559

Sponsors and collaborators

Lead sponsor

University of Bari Aldo Moro

Other

Registry information

Official study title

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

Acronym: ICARUS

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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