Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease

Sponsor

Lithuanian University of Health Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT06072690

Collaborator

(none)

Enrollment

Location

64.5

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Moderate Chronic Obstructive Pulmonary Disease Severe Cardiovascular Diseases Quality of Life

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Impact of Dual Bronchodilation on Respiratory and Cardiovascular Systems in Patients With Newly Diagnosed Moderate-to-severe Chronic Obstructive Pulmonary Disease

Actual Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Aug 31, 2026

Anticipated Study Completion Date :

Aug 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Patients with treatment-naive moderate-to-severe COPD Patients of any gender aged 40 years and older with newly diagnosed treatment-naive moderate-to-severe chronic obstructive pulmonary disease will have a comprehensive cardiovascular and respiratory examination as well as evaluation of quality of life before the treatment and after 12 weeks of treatment with dual bronchodilation.

Outcome Measures

Primary Outcome Measures

Change from baseline in exercise capacity at week 12 [Baseline and week 12]
The effect of dual bronchodilation on exercise capacity (6 minute walk distance test and cardiopulmonary exercise test results) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease
Change from baseline in Short Form 36 Health Survey Questionnaire at week 12 [Baseline and week 12]
The effect of dual bronchodilation on quality of life (Short Form 36 Health Survey Questionnaire (SF-36) results) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease

Secondary Outcome Measures

Change from baseline in forced expiratory volume in 1 second at week 12 [Baseline and week 12]
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 from baseline in forced vital capacity at week 12 [Baseline and week 12]
The effect of dual bronchodilation on forced vital capacity (FVC) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease
Change from baseline in diffusing capacity of the lungs for carbon monoxide at week 12 [Baseline and week 12]
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
Change from baseline in airway resistance at week 12 [Baseline and week 12]
The effect of dual bronchodilation on airway resistance (described as specific air resistance (sRaw) and total airway resistance (Raw tot)) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease
Change from baseline in residual volume at week 12 [Baseline and week 12]
The effect of dual bronchodilation on residual volume (RV) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease
Change from baseline in residual volume to total lung capacity ratio at week 12 [Baseline and week 12]
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 from baseline in forced residual capacity to total lung capacity ratio at week 12 [Baseline and week 12]
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 from baseline in right ventricle end-systolic volume index at week 12 [Baseline and week 12]
The effect of dual bronchodilation on right ventricle end-systolic volume index (RVESVi) in patients with newly diagnosed moderate-to-severe COPD
Change from baseline in right ventricle end-diastolic volume index at week 12 [Baseline and week 12]
The effect of dual bronchodilation on right ventricle end-diastolic volume index (RVEDVi) in patients with newly diagnosed moderate-to-severe COPD
Change from baseline in on left ventricle end-systolic volume index at week 12 [Baseline and week 12]
The effect of dual bronchodilation on left ventricle end-systolic volume index (LVESVi) in patients with newly diagnosed moderate-to-severe COPD
Change from baseline in left ventricle end-diastolic volume index at week 12 [Baseline and week 12]
The effect of dual bronchodilation on left ventricle end-diastolic volume index (LVEDVi) in patients with newly diagnosed moderate-to-severe COPD
Change from baseline in stroke volume index at week 12 [Baseline and week 12]
The effect of dual bronchodilation on stroke volume index (SVi) in patients with newly diagnosed moderate-to-severe COPD
Change from baseline in right ventricular strains at week 12 [Baseline and week 12]
The effect of dual bronchodilation on right ventricular strains in patients with newly diagnosed moderate-to-severe COPD
Change from baseline in washout rate at week 12 [Baseline and week 12]
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 from baseline in heart to mediastinum ratio at week 12 [Baseline and week 12]
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 from baseline in left ventricle total defect score at week 12 [Baseline and week 12]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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