NCT06351345 · Bastiaan Driehuys
129 Xenon Imaging in Patients Treated With Sotatercept
(Sox-PH)
What this study is about
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).
View original scientific description
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 outcome measures
Change in Xenon MRI Red Blood Cell (RBC) percentage
Time frame: baseline, 3,and 12 months
Change in cardiogenic oscillation amplitudes
Time frame: baseline, 3, and 12 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Durham, North Carolina
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 24, 2026 · Source of record for eligibility and locations