Pulmonary and Total Blood Volume in COPD

NCT07428785 | Recruiting DMC

• 1 other identifier: H-25045320
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Healthy Subjects

Keywords

TBV; PBV; COPD; Pulmonary blood volume; Total blood volume

Outcome Measures

Primary Outcomes (1)

• Between-group difference in Pulmonary- and total blood volume ratio (PBV/TBV-ratio)

  day 2

Secondary Outcomes (7)

• pulmonary capillary blood volume/pulmonary blood volume ratio (VC/PBV-ratio)

  day 2

• Between-group difference in total blood volume (TBV)

  day 2

• Between-group difference in Pulmonary blood volume (PBV)

  day 2

• Between-group difference in total red blood cell volume

  day 2

• Between-group difference in total plasma volume

  day 2

Other Outcomes (28)

• Between-group difference in lung tissue mass (LTM)

  day 2

• Between-group difference in diffusion capacity, nitrogen oxide ( DL,NO) (mmol/(min kPa)) during upright rest

  day 2

• Between-group difference in diffusion capacity, nitrogen oxide (DL,CO,5s) (mmol/(min kPa)) during upright rest

  day 2

Study Arms (2)

Healthy controls

healthy matched controls by sex, age, height to the COPD group

Chronic obstructive pulmonary disease (COPD)

patients with COPD

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sjælland, Denmark

You may qualify if:

• Men and women
• years
• COPD (GOLD stage I to III)
• Men and women
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Copenhagen University Hospital, Rigshospitalet: lead

Study Sites (1)

Center for Aktiv Sundhed

Copenhagen, 2100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

A total of six blood samples (9 mL each) will be collected, corresponding to 54 mL per participant. No biobank will be established, and all samples will be analyzed immediately.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronan MG Berg, MD, DMSc

  Center for Aktiv Sundhed, rigshospitalet

  STUDY DIRECTOR

Central Study Contacts

Ronan MG Berg, MD, DMSc

CONTACT

004535451825; ronan@sund.ku.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMSc, Professor

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: February 24, 2026
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)