Endothelial Cell Activation and Total Pulmonary Resistance in PAH

ConditionPulmonary Artery Hypertension

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorImperial College London

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

XBD173
Drug
Participants will be treated with XBD173 90mg twice daily for 6 weeks

Treatment groups

6 Participants

are divided into 1 treatment group

Group A: XBD173Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Percentage change in plasma markers

Time frame

6 weeks

Percentage change in total pulmonary resistance

Time frame

6 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College London

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: