RecruitingPhase 2NCT06351345
129 Xenon Imaging in Patients Treated With Sotatercept
129Xenon MR Imaging and Spectroscopy Response to Sotatercept in Pulmonary Arterial Hypertension
Sponsor
Bastiaan Driehuys
Enrollment
14 participants
Start Date
Oct 27, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
Determine the ability of 129Xe MRI/MRS biomarker signatures to non-invasively monitor pulmonary vascular reverse remodeling induced by sotatercept in pulmonary arterial hypertension (PAH).
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria5
- Outpatients of either gender, Age 18-75
- Diagnosis of precapillary PH (right heart catheterization demonstrating hemodynamic criteria of a mean pulmonary artery pressure (mPAP) ≥ 20 mmHg, pulmonary vascular resistance ≥ 5 WU, pulmonary capillary wedge pressure ≤ 15 mmHg) in the setting of Group 1 (PAH)
- Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
- On a stable dose of background PAH therapy for \> 90 days prior to study enrollment
- Women of childbearing potential must have a negative urine pregnancy test before MRI
Exclusion Criteria8
- Moderate to severe heart disease (LVEF \< 45%, Severe LV hypertrophy, Moderate to severe valvular disease)
- Chronic thromboembolic disease
- PH due to schistosomiasis
- Active cancer
- Sickle cell anemia
- 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 participant or interfere with the participant's ability to comply with the protocol requirements
Interventions
DRUG129Xe Hyperpolarized
Each xenon dose will be limited to a volume less than 25% of participant lung capacity (TLC).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06351345
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