Not Yet RecruitingNot Applicable

Endothelial Cell Activation and Total Pulmonary Resistance in PAH

6 participantsStarted 2026-08-01

Plain-language summary

To determine whether changes in endothelial cell dysfunction are associated with changes in total pulmonary resistance in patients with pulmonary arterial hypertension

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Subjects aged between 18-75 years old
✓. PAH which is: idiopathic; PAH heritable; PAH associated with connective tissue disease; PAH after ≥ 1 year repair of congenital systemic to pulmonary shunt; or PAH associated with anorexignes or other drugs.
✓. Resting mean pulmonary artery pressure ≥25 mmHg, pulmonary capillary wedge pressure ≤15 mmHg, PVR \>5 wood units, and normal or reduced cardiac output, as measured by a previous right heart catheterisation (RHC).
✓. Have an insertable FDA/CE cardiac rhythm monitor and pulmonary artery pressure monitor that captures cardiopulmonary haemodynamics and daily activity.
✓. Six-minute walking distance \>50m at entry
✓. Stable on an unchanged PAH therapeutic regime comprising at least 2 therapies licensed for PAH (any combination of endothelin receptor antagonist, phosphodiesterase inhibitor or prostacyclin analogue) for at least 1 month prior to screening
✓. Subjects willing to be genotyped for genes that influence XBD173 activity
✓. Able to provide written informed consent prior to any study mandated procedures

Exclusion criteria

✕. Unable to provide informed consent and/or are non-fluent speakers of the English language
✕. Hypersensitivity to XBD173 or to any of the excipients
✕. Clinically-significant renal disease (confirmed by creatinine clearance \<30 ml/min per 1.73m2)
✕. Clinically-significant liver disease (confirmed by serum transaminases \>2 times than upper normal limit)
✕. Anaemia confirmed by haemoglobin concentration \<10 g/dl
✕. Individuals known to have haemoglobinopathy sickle cell disease, thalassaemia
✕. Hospital admission related to PAH or change in PAH therapy within 3 months prior to screening
✕. History of left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:

What they're measuring

Percentage change in plasma sVCAM1, e-selectin, GDF-15 and NT-proBNP

Timeframe: 6 weeks

Percentage change in total pulmonary resistance

Timeframe: 6 weeks

Trial details

NCT IDNCT06035861

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-31

View on ClinicalTrials.gov More Pulmonary Artery Hypertension trials