Status:
WITHDRAWN
Xenon MRI in Stable Pulmonary Hypertension (Jupiter AUGEAN)
Lead Sponsor:
Bastiaan Driehuys
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Pulmonary Artery Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 c...
Detailed Description
The clinical and research need for noninvasive biomarkers in pulmonary arterial hypertension (PAH) has led the study team to develop 129Xe magnetic resonance imaging (129Xe MRI) to image pulmonary vas...
Eligibility Criteria
Inclusion
- Stable on current treatment regimen and not planning to undergo initiation of new therapy for at least 3 months
- Outpatients of any gender, Age 18-75
- 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)
- Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
- Women of childbearing potential must have a negative urine pregnancy test before MRI
Exclusion
- Sarcoidosis
- Active cancer
- Sickle cell anemia
- Liver disease (Childs-Pugh class C)
- Any conditions that prevent the performance of 129Xe MRI scans.
- Prisoners and pregnant women will not be approached for the study
- Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
- 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
Key Trial Info
Start Date :
March 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06122922
Start Date
March 15 2024
End Date
December 31 2025
Last Update
January 23 2024
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