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Pulmonary and Total Blood Volume in COPD

Study acronym: COPD-TBV
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Enrollment reopened Show 5 more changesShow less
    • Lead sponsor: Rigshospitalet, Denmark to Copenhagen University Hospital, Rigshospitalet
    • Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 3 of 7 entries
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07428785
Lead Sponsor Copenhagen University Hospital, Rigshospitalet
Conditions
(from sponsor)
COPD (Chronic Obstructive Pulmonary Disease), Healthy Subjects
Related terms Pulmonary Disease, Chronic Obstructive
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov