Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT06072690

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2026-08-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD group

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.

No interventions assigned to this group

Non-COPD group

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

No interventions assigned to this group

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Skaidrius Miliauskas

Head of Pulmonology Department, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Skaidrius Miliauskas, PhD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Lithuanian University of Health Sciences, Medical Academy, Department of Pulmonology

Locations

Lithuanian University of Health Sciences

Kaunas, , Lithuania

Site Status: RECRUITING

Countries

Lithuania

Central Contacts

Skaidrius Miliauskas, PhD, Prof.

Role: CONTACT

skaidrius.miliauskas@lsmu.lt

+37037326269

Ieva Dimiene, MD

Role: CONTACT

ieva.dimiene@lsmu.lt

+3737326953

Facility Contacts

Rimantas Benetis, PhD, Prof.

Role: primary

rektoratas@lsmuni.lt

+37037327200

Other Identifiers

COPDCVS1

Identifier Type: -

Identifier Source: org_study_id