129Xe MRI to monitor sotatercept treatment in pulmonary arterial hypertension
129Xenon MR Imaging and Spectroscopy Response to Sotatercept in Pulmonary Arterial Hypertension
This will test whether hyperpolarized 129Xe MRI scans can noninvasively track lung blood-vessel improvement in adults with pulmonary arterial hypertension treated with sotatercept.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06351345 on ClinicalTrials.gov |
What this trial studies
Adults with Group 1 PAH who are starting sotatercept will undergo hyperpolarized 129Xe MRI/MRS at baseline, 3 months, and 12 months alongside standard clinical tests. Quantitative 129Xe metrics — ventilation defect, RBC defect percentage, membrane uptake percentage, and MRS oscillation amplitude — will be measured and compared with echocardiography, NT-proBNP, six-minute walk distance, labs, and clinical events. The investigators will determine whether baseline and changes in 129Xe signatures predict short- and long-term treatment response, pulmonary vascular reverse remodeling, hospitalizations, and death better than routine risk assessments. The single-center study uses advanced gas-exchange MRI at Duke to explore an imaging biomarker that could improve outcome measurement and reduce future trial size.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 with right-heart-catheterization–confirmed Group 1 PAH who are on stable background therapy and are starting sotatercept and can safely undergo MRI.
Not a fit: Patients with moderate to severe left heart disease, chronic thromboembolic disease, schistosomiasis-associated PH, active cancer, sickle cell anemia, pregnancy, incarceration, or any contraindication to MRI are excluded and unlikely to benefit from this imaging-focused protocol.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive, sensitive imaging biomarker to detect pulmonary vascular remodeling earlier and help guide treatment decisions.
How similar studies have performed: Hyperpolarized 129Xe MRI has shown promise for detecting ventilation and gas-exchange abnormalities in other lung conditions, but using these signatures to monitor vascular remodeling in sotatercept-treated PAH is novel and largely unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Sudarshan Rajagopal, MD, PhD — Duke University
- Study coordinator: Claudia Salazar
- Email: claudia.salazar@duke.edu
- Phone: +1 919 660 2026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.