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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-08-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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COPD (Chronic Obstructive Pulmonary Disease) Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Given the unique intervention, it is expected that the department's daily practices may change during the study due to exposure to the intervention (increased cardiovascular screening and treatment in COPD patients). This could directly impact the intervention's effectiveness. In addition, the quality of treatment and personnel in each department might affect the compliance with the cardiologists recommendations. Therefore, randomization will not be made at the individual or department level, but rather consecutive patients will first be recruited to the control group, followed by 3 weeks of wash-out, and then recruited for the intervention.

COPD patients will be identified by their treating physicians and referred to the research team.

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

The interviewer in the 1, 3, 6 and 12 months phone call follow-up will be blinded to group allocation.

Study Groups

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Intervention

Patients will be evaluated by a pulmonologist during their admission, in addition to a cardiologist, aiming to identify cardiovascular comorbidities including dyslipidemia, diabetes, hypertension, ischemic heart disease, heart failure, valvular disease, personal or family history of ischemic heart disease, and smoking. Part of the evaluation will include assessing the management of diagnosed cardiovascular conditions. Finally, recommendations for further investigation or initiation of drug treatment will be made.

Group Type EXPERIMENTAL

Cardiologist evaluation

Intervention Type 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

Intervention Type OTHER

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

Control

Patients will be evaluated by a pulmonologist during their hospitalization, who will focus on their pulmonary condition, optimize basic treatment, and recommend continued follow-up as needed.

Group Type ACTIVE_COMPARATOR

Pulmonologist evaluation

Intervention Type OTHER

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

Interventions

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Cardiologist evaluation

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.

Intervention Type OTHER

Pulmonologist evaluation

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

Intervention Type OTHER

Eligibility Criteria

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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.