RecruitingNCT06072690

Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease

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


Sponsor

Lithuanian University of Health Sciences

Enrollment

80 participants

Start Date

Apr 15, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 40 Years

Inclusion Criteria3

  • 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 Criteria13

  • 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

Locations(1)

Lithuanian University of Health Sciences

Kaunas, Lithuania

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NCT06072690


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