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

NCT06723795 | Recruiting

• 1 other identifier: 0510-24-TLV
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Cardiovascular Diseases

Keywords

COPD exacerbation; Cardiovascular disease; Comorbidity; Diagnosis; Screening

Outcome Measures

Primary Outcomes (1)

• Cardiovascular-related treatment change in 6 months

  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.

  From enrollment to 6 months follow-up call

Secondary Outcomes (7)

• Diagnosis of new cardiovascular comorbidity

  From inclusion to hospital discharge

• Extended diagnosis of new cardiovascular comorbidity

  At 6 months after enrollment.

• Adverse outcomes

  At 3 and 6 months from study enrollment

• MACE

  At 3 and 6 months from enrollment

• Time to MACE

  6 months from enrollment

Other Outcomes (8)

• Time to COPD exacerbation

  6 moths from enrollment

• Adherence to new treatment

  6 months from enrollment

• Smoking cessation

  6 and 3 months from enrollment

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Cardiologist evaluation; Other: Pulmonologist evaluation

Control

ACTIVE COMPARATOR

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.

Other: Pulmonologist evaluation

Interventions

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.

Intervention

Pulmonologist evaluation OTHER

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

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Related Publications (4)

• Vogelmeier C, Simons S, Garbe E, et al. Increased risk of severe cardiovascular events following exacerbations of COPD: a multi-database cohort study. Eur Respir J. 2023;62(suppl 67). doi:10.1183/13993003.congress-2023.PA3013

  BACKGROUND

• Swart KMA, Baak BN, Lemmens L, Penning-van Beest FJA, Bengtsson C, Lobier M, Hoti F, Vojinovic D, van Burk L, Rhodes K, Garbe E, Herings RMC, Nordon C, Simons SO. 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. Respir Res. 2023 Nov 21;24(1):293. doi: 10.1186/s12931-023-02601-4.

  PMID: 37990197 BACKGROUND

• Hawkins NM, Peterson S, Ezzat AM, Vijh R, Virani SA, Gibb A, Mancini GBJ, Wong ST. Control of Cardiovascular Risk Factors in Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2022 Jul;19(7):1102-1111. doi: 10.1513/AnnalsATS.202104-463OC.

  PMID: 35007497 BACKGROUND

• Feary JR, Rodrigues LC, Smith CJ, Hubbard RB, Gibson JE. Prevalence of major comorbidities in subjects with COPD and incidence of myocardial infarction and stroke: a comprehensive analysis using data from primary care. Thorax. 2010 Nov;65(11):956-62. doi: 10.1136/thx.2009.128082. Epub 2010 Sep 25.

  PMID: 20871122 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Disease

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ophir Freund, MD

CONTACT

+972-545-305648; Ophirf@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The interviewer in the 1, 3, 6 and 12 months phone call follow-up will be blinded to group allocation.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)