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Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
ID06351345

Using 129Xenon MRI and Spectroscopy to Monitor Response to Sotatercept Treatment in Adults with 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 MRIMRS 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 MRIMRS 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 MRIMRS 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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Research Team

C

Claudia Salazar

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