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NCT Number: NCT06723795

Cardiovascular Assessment and Treatment During COPD Exacerbation to Improve Diagnosis and Outcomes

This is a research study involving patients hospitalized for COPD flare-ups. Patients will be randomly assigned to two groups: one group will only see a pulmonologist (lung doctor), and the other group will also be seen by a cardiologist (heart doctor) during their hospital stay. Both groups will fill out a questionnaire, and the pulmonologist will review their lung disease, adjust their treatment, and recommend follow-up care. The cardiologist will also assess the second group for heart diseases (like high cholesterol, diabetes, heart disease, high blood pressure, or heart failure) and start or adjust heart treatment if needed. Both groups will be followed up by phone 1, 3, 6 and 12 months later to check for changes in treatment, new heart problems, COPD flare-ups, or death.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

About this study

This is a single-center, prospective, randomized study involving patients hospitalized for COPD exacerbation. Eligible patients will be identified either by the internal medicine department doctors or by reviewing the admission diagnoses of hospitalized patients in the hospital's database. After obtaining informed consent, the patients will be randomized into two groups.

Both groups will complete a background questionnaire and will be assessed by a pulmonologist during the hospitalization, who will focus on their lung disease, optimize basic treatment, and recommend follow-up as needed. The intervention group will undergo an additional evaluation by a cardiologist during the hospitalization, who will check for cardiovascular diseases (such as hyperlipidemia, diabetes, ischemic heart disease, hypertension, or heart failure) and adjust or start treatment according to new or existing diagnoses.

Both groups will receive follow-up phone calls about 1, 3, 6, and 12 months later to evaluate any changes in treatment following the intervention, new diagnoses or events of cardiovascular diseases, COPD exacerbations, and mortality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented COPD (based on lung function tests, symptoms and relevant treatment).
  • Aged 18-75 years.
  • Mentally competent to understand and follow medical recommendations.

Exclusion criteria

  • Under 18 years of age.
  • Unable to provide consent.
  • Unstable concurrent disease.

Treatment and study plan

Cardiologist evaluation

Other

The cardiology consultation will include the following: a structured interview (see Appendix A), physical examination, review of laboratory tests including HbA1c, lipid profile, BNP, ECG, and POCUS (point-of-care ultrasound) to assess heart contraction and valve function.

Pulmonologist evaluation

Other

optimize basic treatment, and recommend continued follow-up as needed.

Primary outcomes

  1. Cardiovascular-related treatment change in 6 months

    Time frame: From enrollment to 6 months follow-up call

    New pharmacological treatment or intervention (e.g., angiography, surgery) for cardiovascular disease, including diabetes, hypertension, dyslipidemia, ischemic heart disease, stroke, valvular disease, or heart failure compared to at inclusion.

Secondary outcomes

  1. Diagnosis of new cardiovascular comorbidity

    Time frame: From inclusion to hospital discharge

    Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure.

  2. Extended diagnosis of new cardiovascular comorbidity

    Time frame: At 6 months after enrollment.

    Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure.

  3. Adverse outcomes

    Time frame: At 3 and 6 months from study enrollment

    Combined outcome of Major Adverse Cardiovascular Events (MACE - stroke, myocardial infarction, cardiovascular mortality) and readmissions or mortality due to COPD

  4. MACE

    Time frame: At 3 and 6 months from enrollment

    Occurrence of MACE - MACE - stroke, myocardial infarction, cardiovascular mortality.

  5. Time to MACE

    Time frame: 6 months from enrollment

    Time from enrollment to first MACE - stroke, myocardial infarction, cardiovascular mortality

  6. COPD exacerbations

    Time frame: 3 and 6 months from enrollment

    Amount of COPD exacerbations, defined as an event characterized by an acute change in the patient's baseline dyspnoea, cough, and/or sputum that warrant a change in regular medication.

  7. COPD severe exacerbations

    Time frame: 6 months from study recruitment

    Amount of COPD exacerbations that leads to hospitalization

Other outcomes

  1. Time to COPD exacerbation

    Time frame: 6 moths from enrollment

    Time to COPD exacerbation, defined as an event characterized by an acute change in the patient's baseline dyspnea, cough, and/or sputum that warrant a change in regular medication.

  2. Adherence to new treatment

    Time frame: 6 months from enrollment

    Adherence to newly initiated pharmacological treatment from the study intervention

  3. Smoking cessation

    Time frame: 6 and 3 months from enrollment

    Rates of smoking cessation between the intervention and control groups among smokers

  4. Specialists follow-up

    Time frame: 6 months from enrollment

    Rate of patients with cardiologist and pulmonologist visits

  5. Post-Hoc analysis - Treatment

    Time frame: 12 months from recruitment

    New pharmacological treatment or intervention (e.g., angiography, surgery) for cardiovascular disease, including diabetes, hypertension, dyslipidemia, ischemic heart disease, stroke, valvular disease, or heart failure compared to at inclusion.

  6. Post-HOC analysis - diagnoses

    Time frame: 12 months from recruitment

    Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure.

  7. Post-HOC analysis - COPD exacerbations

    Time frame: 12 months from recruitment

    COPD exacerbations requiring steroids or hospital arrival

  8. Post-HOC analysis - MACE

    Time frame: 12 months from recruitment

    Occurance of MACE between the intervention and control

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Collaborators

  • AstraZeneca

Registry information

Official study title

Early Cardiovascular Risk Assessment of Patients With COPD During Respiratory Exacerbation for the Identification and Treatment of Cardiovascular Comorbidity

Acronym: CATCH

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2024
Registry last updated
Jun 22, 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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