129Xe MRI to monitor sotatercept treatment in pulmonary arterial hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rutgers Genetics of Pulmonary Hypertension

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• Using Xenon MRI to study pulmonary hypertension

  This study is testing if a special type of MRI can help understand how lung changes in people with pulmonary arterial hypertension affect their breathing and overall health.

  Recruiting Phase 2 Duke University · Durham, North Carolina · NCT04991454

• Registry and biorepository for pulmonary hypertension patients

  This study is setting up a collection of health information and blood samples from people with pulmonary hypertension to help researchers learn more about the disease and improve treatments.

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• Treatment for pulmonary arterial hypertension using a new device

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.