Cardiovascular Diseases, Chronic Obstructive Pulmonary Disease Moderate, Chronic Obstructive Pulmonary Disease Severe, Quality of Life
Conditions
Keywords
COPD, cardiac autonomic integrity, cardiac function, dual bronchodilation, biomarkers, quality of life
Brief summary
Chronic obstructive pulmonary disease (COPD) is a lung condition characterized by chronic respiratory symptoms (dyspnoea, cough, sputum production and/or exacerbations) due to abnormalities of the airways (e.g. bronchitis, bronchiolitis) and/or alveoli (emphysema) that lead to persistent, often progressive, airflow obstruction. It is a major cause of disability and death worldwide. Moreover, 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. In the past years, 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. However, there is a lack of studies with treatment-naïve patients that would describe the initial effect of dual bronchodilation on respiratory and cardiovascular systems. In this study we aimed to evaluate the effect of initial dual bronchodilation on the quality of life, respiratory and cardiovascular systems in patients with newly-diagnosed chronic obstructive pulmonary disease.
Interventions
None listed
Sponsors
Lithuanian University of Health Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in oxygen uptake at peak exercise after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on peak oxygen uptake (VO2) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease |
| Change in health-related quality of life after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on health related quality of life (evaluating using the Short Form 36 Health Survey (SF-36) Questionnaire) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in forced expiratory volume in 1 second after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on forced expiratory volume in 1 second (FEV1) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease |
| Change in forced vital capacity after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on forced vital capacity (FVC) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease |
| Change in residual volume after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on residual volume (RV) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease |
| Change in residual volume to total lung capacity ratio after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on residual volume to total lung capacity ratio (RV/TLC) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease |
| Change in forced residual capacity to total lung capacity ratio after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on forced residual capacity to total lung capacity ratio (FRC/TLC) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease |
| Change in diffusing capacity of the lungs for carbon monoxide after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on diffusing capacity of the lungs for carbon monoxide (DLCO) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease |
| Changes in the inner area of segmental bronchi after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on the structure of segmental bronchi measured in CT scan in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease |
| Change in right ventricle end-systolic volume index after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on right ventricle end-systolic volume index (RVESVi) in patients with newly diagnosed moderate-to-severe COPD |
| Change in right ventricle end-diastolic volume index after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on right ventricle end-diastolic volume index (RVEDVi) in patients with newly diagnosed moderate-to-severe COPD |
| Change in right ventricular strain after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on right ventricular (RV) strain in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease |
| Change in left ventricle end-systolic volume index after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on left ventricle end-systolic volume index (LVESVi) in patients with newly diagnosed moderate-to-severe COPD |
| Change in left ventricle end-diastolic volume index after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on left ventricle end-diastolic volume index (LVEDVi) in patients with newly diagnosed moderate-to-severe COPD |
| Change in stroke volume index after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on stroke volume index (SVi) in patients with newly diagnosed moderate-to-severe COPD |
| Change in washout rate after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on washout rate (WR) in cardiac sympathetic imaging with meta-iodobenzylguanidine in patients with newly diagnosed moderate-to-severe COPD |
| Change in heart to mediastinum ratio after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on early and late heart to mediastinum ratio (HMR) in cardiac sympathetic imaging with meta-iodobenzylguanidine in patients with newly diagnosed moderate-to-severe COPD |
| Change in left ventricle total defect score after 12 weeks of dual bronchodilation | Baseline to 12 weeks | The effect of dual bronchodilation on early and late left ventricle early total defect score (TDS) in cardiac sympathetic imaging with meta-iodobenzylguanidine in patients with newly diagnosed moderate-to-severe COPD |
| Differences in health-related quality of life between COPD and non-COPD individuals | Baseline | — |
| Differences in exercise capacity between COPD and non-COPD individuals | Baseline | — |
| Differences in right ventricular (RV) measurements between COPD and non-COPD individuals | Baseline | — |
Countries
Lithuania
Contacts
CONTACTSkaidrius Miliauskas, PhD, Prof.
CONTACTIeva Dimiene, MD
PRINCIPAL_INVESTIGATORSkaidrius Miliauskas, PhD, Prof.
Lithuanian University of Health Sciences, Medical Academy, Department of Pulmonology
Outcome results
None listed