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
Sex
ALL
Min age
45 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Inclusion criteria -patients
* Men and women
* 45-80 years
* COPD (GOLD stage I to III)
* Resting arterial oxygenation \> 90% Inclusion criteria - controls
* Men and women
* 45-80 years
* Normal FEV1, FVC, FEV1/FVC, and single-breath diffusion capacity
* Same sex, age (± 3 years) and height (± 5 cm) as an included COPD patient
* Low- to moderate activity level defined as \< 1,5 hours of structured physical activity pr. week at moderate intensity and cycling \< 30 minutes/5km pr. day at moderate intensity (moderate intensity = out of breath but able to speak)
Exclusion Criteria:
Exclusion criteria - patients
* Symptoms of ischaemic heart disease
* Known heart failure
* Previous severe or current COVID-19
* Claudication
* Symptoms of disease within 2 weeks prior to the study
* Participation in pulmonary rehabilitation within 6 months
* Known malignant disease
* Pregnancy
* Unstable cardiac arrhythmic disease
* Renal or liver dysfunction
Exclusion criteria - controls
* Known chronic lung disease
* Known ischaemic heart disease
* Known heart failure
* Previous severe or current COVID-19
* Symptoms of disease within 2 weeks prior to the study
* Known malignant disease
* Claudication
* Pregnancy
* Unstable cardiac arrhythmic disease
* Renal or liver dysfunction
Primary outcome measure(s)
Between-group difference in Pulmonary- and total blood volume ratio (PBV/TBV-ratio) — day 2
Trial sites (1)
Facility
City
Region
Status
Center for Aktiv Sundhed
Copenhagen
Denmark
More Copenhagen University Hospital, Rigshospitalet trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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