NCT06351345 129 Xenon Imaging in Patients Treated With Sotatercept
| NCT ID | NCT06351345 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Bastiaan Driehuys |
| Condition | Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2029-02-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 14 participants in total. It began in 2025-10-27 with a primary completion date of 2029-02-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Outpatients of either gender, Age 18-75 2. 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) 3. Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed). 4. On a stable dose of background PAH therapy for \> 90 days prior to study enrollment 5. Women of childbearing potential must have a negative urine pregnancy test before MRI Exclusion Criteria: 1. Moderate to severe heart disease (LVEF \< 45%, Severe LV hypertrophy, Moderate to severe valvular disease) 2. Chronic thromboembolic disease 3. PH due to schistosomiasis 4. Active cancer 5. Sickle cell anemia 6. Prisoners and pregnant women will not be approached for the study 7. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine) 8. 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
Contact & Investigator
Sudarshan Rajagopal, MD, PhD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06351345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06351345 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06351345 currently recruiting?
Yes, NCT06351345 is actively recruiting participants. Contact the research team at claudia.salazar@duke.edu for enrollment information.
Where is the NCT06351345 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06351345 clinical trial?
NCT06351345 is sponsored by Bastiaan Driehuys. The principal investigator is Sudarshan Rajagopal, MD, PhD at Duke University. The trial plans to enroll 14 participants.