About this trial
Background Patients with chronic obstructive lung disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. This is markedly affected by a reduced exercise capacity and dyspnoea, but the underlying mechanisms are unknown. In the present study, we aim to investigate whether this may involve a reduced pulmonary blood volume secondarily to a reduced total blood volume.
Methods Design: Prospective matched comparative study Intervention: None
Outcomes:
The primary outcome is pulmonary blood volume estimated to total blood volume ratio between patients with COPD and healthy controls individually matched for age, sex, and height.
Statistical design:
All statistical analyses will be performed using R statistical software version 4.1.1 (R Project for Statistical Computing) within RStudio statistical software version 1.4.1717 (RStudio), and a two-tailed p\<0.05 will be considered statistically significant. Inspection of normality and variance homogeneity will be done by creating qq-plots and histogram.
Regulatory considerations: This study will be submitted for approval by Regional Ethical Committee.
Perspective: This study will help uncover fundamental aspects of the pathophysiology of COPD.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Inclusion criteria -patients
Men and women
45-80 years
COPD (GOLD stage I to III)
Disqualifiers
Symptoms of ischaemic heart disease
Known heart failure
Previous severe or current COVID-19
Claudication
Trial population
Sjælland, Denmark
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Between-group difference in Pulmonary- and total blood volume ratio (PBV/TBV-ratio)
Secondary outcomes
pulmonary capillary blood volume/pulmonary blood volume ratio (VC/PBV-ratio)
Between-group difference in total blood volume (TBV)
Between-group difference in Pulmonary blood volume (PBV)
Between-group difference in total red blood cell volume
Other outcomes
Between-group difference in lung tissue mass (LTM)
Between-group difference in diffusion capacity, nitrogen oxide ( DL,NO) (mmol/(min kPa)) during upright rest
Between-group difference in diffusion capacity, nitrogen oxide (DL,CO,5s) (mmol/(min kPa)) during upright rest
Between-group difference in Pulmonary capillary blood volume (VC) during upright rest
Sponsors and contacts
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