Recruiting
129 Xenon Imaging in Patients Treated With Sotatercept
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).
ClinicalTrials.gov IDNCT06351345
PhasePHASE2
Enrollment14
SponsorBastiaan Driehuys
Age18 Years
SexALL
Conditions studied
Pulmonary Hypertension, Pulmonary Arterial Hypertension
About this study
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).
Interventions
- Drug: 129Xe Hyperpolarized — Each xenon dose will be limited to a volume less than 25% of participant lung capacity (TLC).
Primary outcomes
- Change in Xenon MRI Red Blood Cell (RBC) percentage (baseline, 3,and 12 months)
- Change in cardiogenic oscillation amplitudes (baseline, 3, and 12 months)
Eligibility information
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
Study locations
- Duke University Medical Center, Durham, North Carolina 27710 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.