Actively Recruiting
129Xenon MR Imaging and Spectroscopy Response to Sotatercept in Pulmonary Arterial Hypertension
Led by Bastiaan Driehuys · Updated on 2026-02-24
14
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
Bastiaan Driehuys
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 129Xe MRI/MRS biomarker signatures to non-invasively monitor changes in the lungs of patients with pulmonary arterial hypertension (PAH) who are treated with sotatercept. The study aims to predict short- and long-term responses to sotatercept and improve assessment of treatment outcomes compared to current standard methods. PAH involves blood vessel remodeling in the lungs that leads to heart failure and reduced lung function, and sotatercept is being studied for its potential to reverse these changes. Participants with PAH receiving sotatercept as part of their clinical care will undergo 129Xe MRI/MRS scans at baseline, 3 months, and 12 months. These scans measure ventilation defects, blood volume in lung capillaries, lung wall thickness and inflammation, and heart-related oscillations. Alongside the imaging, standard assessments such as laboratory tests, heart ultrasound, NTproBNP blood tests, and a 6-minute walk test will be performed at each visit. During the study, participants will have multiple visits to complete imaging, lab work, and functional tests to monitor lung and heart function. Researchers will track changes in specific MRI/MRS biomarkers and cardiogenic oscillation amplitudes over time to evaluate treatment effects. The study includes safety monitoring and will last until at least 12 months after starting sotatercept treatment.
CONDITIONS
Brief Title
129 Xenon Imaging in Patients Treated With Sotatercept
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients of either gender aged 18 to 75 years
- Diagnosis of precapillary pulmonary hypertension (Group 1 PAH) confirmed by right heart catheterization
- Willing to give informed consent and follow the visit and protocol schedule
- On a stable dose of background PAH therapy for more than 90 days prior to enrollment
- Women of childbearing potential must have a negative urine pregnancy test before MRI
You will not qualify if you...
- Moderate to severe heart disease (LVEF less than 45%, severe left ventricular hypertrophy, moderate to severe valvular disease)
- Chronic thromboembolic disease
- Pulmonary hypertension due to schistosomiasis
- Active cancer
- Sickle cell anemia
- Prisoners and pregnant women will not be approached
- Conditions preventing MRI scanning (metal in eye, claustrophobia, inability to lie supine)
- Medical or psychological conditions that may increase risk or interfere with study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants undergo 129Xe MRI/MRS scans and standard-of-care assessments to evaluate pulmonary vascular remodeling before and during treatment with sotatercept.
3 visits at baseline, 3 months, and 12 months
Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
C
Claudia Salazar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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