Xenon MRI in Stable Pulmonary Hypertension (Jupiter AUGEAN)

• Status: Withdrawn
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this project is to determine how pulmonary vascular remodeling in Pulmonary Arterial Hypertension (PAH) at cellular and pathological level is associated with gas exchange physiology changes and hemodynamics (monitored with 129Xe MRI/MRS) and how these signals change with disease progression or treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bastiaan Driehuys
• Collaborator: Regeneron Pharmaceuticals

Criteria

Inclusion Criteria:

1. Stable on current treatment regimen and not planning to undergo initiation of new therapy for at least 3 months

2. Outpatients of any gender, Age 18-75

3. WHO functional class (FC) 1-3 symptoms with a diagnosis of group 1 PH (mean pulmonary artery pressures (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg and pulmonary vascular resistance (PVR) ≥3 WU)

4. Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).

5. Women of childbearing potential must have a negative urine pregnancy test before MRI

Exclusion Criteria:

6. Sarcoidosis

7. Active cancer

8. Sickle cell anemia

9. Liver disease (Childs-Pugh class C)

10. Any conditions that prevent the performance of 129Xe MRI scans.

11. Prisoners and pregnant women will not be approached for the study

12. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)

13. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements