跳至主要内容
临床试验/NCT06072690
NCT06072690招募中不适用

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

Lithuanian University of Health Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Change from baseline in cardiopulmonary exercise testing at week 12

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Change from baseline in cardiopulmonary exercise testing at week 12

时间窗: Baseline and week 12

The effect of dual bronchodilation on cardiopulmonary exercise test results in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease

Change from baseline in health-related quality of life at week 12

时间窗: Baseline and week 12

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

次要结局

  • Change from baseline in forced expiratory volume in 1 second at week 12(Baseline and week 12)
  • Change from baseline in forced vital capacity at week 12(Baseline and week 12)
  • Change from baseline in diffusing capacity of the lungs for carbon monoxide at week 12(Baseline and week 12)
  • Change from baseline in residual volume at week 12(Baseline and week 12)
  • Change from baseline in residual volume to total lung capacity ratio at week 12(Baseline and week 12)
  • Change from baseline in forced residual capacity to total lung capacity ratio at week 12(Baseline and week 12)
  • Change from baseline in right ventricle end-systolic volume index at week 12(Baseline and week 12)
  • Change from baseline in right ventricle end-diastolic volume index at week 12(Baseline and week 12)
  • Change from baseline in on left ventricle end-systolic volume index at week 12(Baseline and week 12)
  • Change from baseline in left ventricle end-diastolic volume index at week 12(Baseline and week 12)
  • Change from baseline in stroke volume index at week 12(Baseline and week 12)
  • Change from baseline in right ventricular strains at week 12(Baseline and week 12)
  • Change from baseline in washout rate at week 12(Baseline and week 12)
  • Change from baseline in heart to mediastinum ratio at week 12(Baseline and week 12)
  • Change from baseline in left ventricle total defect score at week 12(Baseline and week 12)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Skaidrius Miliauskas

Head of Pulmonology Department, Professor

Lithuanian University of Health Sciences

研究点 (1)

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