Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease

Lithuanian University of Health Sciences

Status: Enrolling

Conditions: Quality of Life; Cardiovascular Diseases; Chronic Obstructive Pulmonary Disease Moderate; Chronic Obstructive Pulmonary Disease Severe

Study type: Observational

Funder types: Other

Identifiers

NCT06072690

COPDCVS1

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

80 participants in 2 patient groups

COPD group

Description:

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.

Non-COPD group

Description:

Subjects 40 years and older without respiratory conditions with similar age, gender and cardiovascular comorbidity profile