Clinical trial NCT06723795: Cardiovascular Assessment During COPD Exacerbation to Improve Diagnosis and Treatment
Official title: Early Cardiovascular Risk Assessment of Patients With COPD During Respiratory Exacerbation for the Identification and Treatment of Cardiovascular Comorbidity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Cardiovascular Diseases
Keywords: COPD exacerbation
Cardiovascular disease
Comorbidity
Diagnosis
Screening
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-12-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 trreatment 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.

After completion of the study follow-up by 50 participants in each group, an interim-analysis will be made. In case that the primary analysis will be achieved, the research team will consider the continuation of recruitment due the lack of funding.
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cardiovascular-related treatment change in 6 months
timeFrame: From enrollment to 6 months follow-up call
Secondary outcomes:
measure: Diagnosis of new cardiovascular comorbidity
timeFrame: From inclusion to hospital discharge
measure: Extended diagnosis of new cardiovascular comorbidity
timeFrame: At 6 months after enrollment.
measure: Adverse outcomes
timeFrame: At 3 and 6 months from study enrollment
measure: MACE
timeFrame: At 3 and 6 months from enrollment
measure: Time to MACE
timeFrame: 6 months from enrollment
measure: COPD exacerbations
timeFrame: 3 and 6 months from enrollment
measure: COPD severe exacerbations
timeFrame: 6 months from study recruitment
Other outcomes:
measure: Time to COPD exacerbation
timeFrame: 6 moths from enrollment
measure: Adherence to new treatment
timeFrame: 6 months from enrollment
measure: Smoking cessation
timeFrame: 6 and 3 months from enrollment
measure: Specialists follow-up
timeFrame: 6 months from enrollment
measure: Post-Hoc analysis - Treatment
timeFrame: 12 months from recruitment
measure: Post-HOC analysis - diagnoses
timeFrame: 12 months from recruitment
measure: Post-HOC analysis - COPD exacerbations
timeFrame: 12 months from recruitment
measure: Post-HOC analysis - MACE
timeFrame: 12 months from recruitment
Locations:
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.