Clinical trial NCT06072690: Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease
Official title: The Impact of Dual Bronchodilation on Respiratory and Cardiovascular Systems in Patients With Newly Diagnosed Moderate-to-severe Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease Moderate
Chronic Obstructive Pulmonary Disease Severe
Cardiovascular Diseases
Quality of Life
Keywords: COPD
cardiac autonomic integrity
cardiac function
dual bronchodilation
biomarkers
quality of life
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cohort will be selected from patients with clinical signs of COPD reffered to the tertiary care outpatient clinic by general physicians from the primary and secondary care clinics.

Brief summary: Chronic obstructive pulmonary disease (COPD) is a major cause of disability and death worldwide. People with COPD often have cardiovascular diseases (CVDs) that are associated with increased risk for hospitalization and prolonged stay as well as all-cause and CVD-related mortality. Nevertheless, CVDs in patients with COPD are tend to be underestimated in clinical practice. Mechanisms that define the relation between COPD and cardiovascular morbidity include lung hyperinflation, hypoxia, pulmonary hypertension, systemic inflammation and oxidative stress, exacerbation, shared risk factors and COPD phenotypes. Recently, some authors have announced that COPD treatment with dual bronchodilation may not only improve pulmonary function and quality of life, but also have a positive effect on cardiac function in cardiac magnetic resonance imaging (MRI) or two-dimensional cardiac ultrasound for the assessments. The aim of this study is to specify the state of respiratory and cardiovascular systems as well as exercise capacity and quality of life in patients with newly diagnosed moderate-to-severe COPD and to evaluate their changes after short-term treatment with dual bronchodilation. We hypothesize that patients with newly diagnosed COPD and no previous records of cardiac diseases and no apparent signs of heart failure have significantly impaired cardiac autonomic integrity that precedes to increased risk of cardiovascular events. It is believed that cardiac autonomic integrity might significantly improve with dual bronchodilation therapy.


Eligibility criteria: Inclusion Criteria:

* Aged 40 years and older
* Smoking index of 10 pack-years and more
* Newly diagnosed chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) 30-79 percent of predicted and forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) less than 70 percent of predicted.

Exclusion Criteria:

* Active lung infection
* Present or previously treated lung cancer
* Alpha-1 antitrypsin deficiency
* Diagnosed interstitial lung disease
* Previously diagnosed asthma
* Diagnosed chronic hypercapnic respiratory failure
* Treatment with systemic glucocorticoids
* Unstable ischaemic heart disease
* Pregnancy
* Present cardiac arrhythmias
* Uncontrolled arterial hypertension
* Dementia and other mental states that determine patient's inability to consent
* Other medical conditions that in the opinion of the investigator disqualify the subject for inclusion

Primary outcomes:
measure: Change from baseline in exercise capacity at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in Short Form 36 Health Survey Questionnaire at week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change from baseline in forced expiratory volume in 1 second at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in forced vital capacity at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in diffusing capacity of the lungs for carbon monoxide at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in airway resistance at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in residual volume at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in residual volume to total lung capacity ratio at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in forced residual capacity to total lung capacity ratio at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in right ventricle end-systolic volume index at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in right ventricle end-diastolic volume index at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in on left ventricle end-systolic volume index at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in left ventricle end-diastolic volume index at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in stroke volume index at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in right ventricular strains at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in washout rate at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in heart to mediastinum ratio at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in left ventricle total defect score at week 12
timeFrame: Baseline and week 12
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
affiliation: Lithuanian University of Health Sciences, Medical Academy, Department of Pulmonology
name: Skaidrius Miliauskas, PhD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: