Cardiovascular Assessment During COPD Exacerbation to Improve Diagnosis and Treatment

Not Applicable

Recruiting

• Conditions: COPD (Chronic Obstructive Pulmonary Disease); Cardiovascular Diseases

• Registration Number: NCT06723795
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-09
• Status Verified: 2025-03
• Study Start: 2025-03-01
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-03-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cardiovascular-related treatment change in 6 months	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 Outcome Measures

Name	Time	Method
Diagnosis of new cardiovascular comorbidity	From inclusion to hospital discharge	Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure.
Extended diagnosis of new cardiovascular comorbidity	At 6 months after enrollment.	Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure.
Adverse outcomes	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
MACE	At 3 and 6 months from enrollment	Occurrence of MACE - MACE - stroke, myocardial infarction, cardiovascular mortality.
Time to MACE	6 months from enrollment	Time from enrollment to first MACE - stroke, myocardial infarction, cardiovascular mortality
COPD exacerbations	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.
COPD severe exacerbations	6 months from study recruitment	Amount of COPD exacerbations that leads to hospitalization

Trial Locations

Locations (1)

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel