Investigating the effect of a medication on the blood pressure within the lungs

Not Applicable

• Conditions: Pulmonary vascular tone and sensitivity to hypoxia and the influence of activation of the hypoxia-inducible factor (HIF) pathway; Not Applicable

• Registration Number: ISRCTN67730811
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-18
• Last Update Posted: 8 January 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male and female, aged 19–60 years old
2. Willing and able to provide informed consent for participation in the study
3. Not currently taking any significant medications (to be reviewed and confirmed on a case-by-case assessment by a clinically qualified researcher)
4. Not taking the combined oral contraceptive pill. The progesterone-only pill (‘mini pill’) is acceptable.
5. No pre-existing significant medical conditions – this will be decided after a case-by-case assessment by a clinically qualified researcher

Exclusion Criteria

1. Inability to tolerate face mask/mouthpiece/nose clip (for experimental procedure)
2. Pregnant or breastfeeding
3. Significant regular medication that could affect the result of the study (interaction with hypoxia or a possible effect on the pulmonary vasculature) and/or has a known interaction with roxadustat.
4. Previous or current significant medical problems may be an exclusion – this will be decided after a case-by-case assessment by a clinical-qualified researcher:
4.1. Pre-existing cardiorespiratory disease
4.2. Pre-existing renal or hepatic impairment
4.3. History of or current significant psychiatric illness
4.4. History of or current significant neurological condition (e.g. epilepsy)
4.5. History of or current venous thromboembolism, pulmonary embolism, or thrombophilia
4.6. Current participation in other research studies
4.7. Recent (within one month) excursions to altitude above 2500 m (with case-by-case assessment for long sojourns); recent (within 1 week) air travel over 4 hours duration
4.8. Known pre-existing anaemia and/or iron deficiency
4.9. Hypersensitivity to peanut or soya (roxadustat tablets contain traces of soya lecithin and a hypersensitivity to peanut or soya is listed as a contraindication to prescription)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Resting pulmonary vascular tone, measured as estimated pulmonary artery systolic pressure (PASP) in mmHg, using non-invasive echocardiography via tricuspid valve regurgitation. This measurement is performed when breathing normal oxygen levels. This is measured at baseline, before roxadustat/placebo, then repeated every 30 minutes for the first 2 hours, then every hour thereafter to a total time of 6 hours.<br>2. PASP, measured as before using echocardiography, in response to acute (20 minutes) and sustained (2 hours) hypoxia. During the 20 minutes of acute hypoxia echocardiography is continually recorded and PASP is measured every minute. 2 hours of hypoxia is then undertaken, during which measurements are not made. Then the 20-minute study is repeated.

Secondary Outcome Measures

Name	Time	Method
Venous blood erythropoietin concentrations before and after roxadustat, measured using blood samples taken at baseline and thereafter at 3 hours and 6 hours