Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06723795

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

Led by Tel-Aviv Sourasky Medical Center · Updated on 2025-09-30

150

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

T

Tel-Aviv Sourasky Medical Center

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate patients hospitalized for COPD flare-ups by comparing two different care approaches. Patients will be randomly assigned to either see only a lung doctor (pulmonologist) or to see both a lung doctor and a heart doctor (cardiologist) during their hospital stay. The study focuses on identifying and managing heart problems that might affect people with COPD, with the goal of improving diagnosis and health outcomes over one year. During hospitalization, all patients will complete a questionnaire. The pulmonologist will review lung disease, adjust treatment, and recommend follow-up care. Those in the intervention group will also be evaluated by a cardiologist, who will assess heart-related conditions such as high cholesterol, diabetes, heart disease, high blood pressure, and heart failure. The cardiologist may start or adjust heart treatments based on this evaluation. Participants will be followed up by phone at 1, 3, 6, and 12 months after hospital discharge. These calls will check for any changes in treatment, new heart problems, COPD flare-ups, or death. Researchers will measure changes in cardiovascular treatment within six months and track new heart disease diagnoses, adverse events, and COPD exacerbations during the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented COPD based on lung function tests, symptoms, and relevant treatment
  • Age between 18 and 75 years
  • Mentally competent to understand and follow medical recommendations
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Hospitalization Evaluation

Duration - Duration of hospital stay

During hospitalization for COPD exacerbation, participants are evaluated by a pulmonologist to optimize lung disease treatment. Participants in the intervention group also receive an additional cardiovascular evaluation by a cardiologist to identify and manage cardiovascular comorbidities.

1 to 2 in-person visits during hospitalization

Follow-up Monitoring

Duration - 12 months

Participants receive follow-up phone calls at 1, 3, 6, and 12 months after hospitalization to monitor treatment changes, new cardiovascular diagnoses, COPD exacerbations, and overall health status.

4 follow-up phone calls

Trial Site Locations

Total: 1 location

1

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Actively Recruiting

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Research Team

O

Ophir Freund, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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Published Research Related To This Trial

Risk of cardiovascular events after an exacerbation of chronic obstructive pulmonary disease: results from the EXACOS-CV cohort study using the PHARMO Data Network in the Netherlands.

Karin M A Swart, Brenda N Baak, Louise Lemmens...

https://pubmed.ncbi.nlm.nih.gov/37990197

Prevalence of major comorbidities in subjects with COPD and incidence of myocardial infarction and stroke: a comprehensive analysis using data from primary care.

Johanna R Feary, Laura C Rodrigues, Christopher J Smith...

https://pubmed.ncbi.nlm.nih.gov/20871122