Using Xenon MRI to study pulmonary hypertension
Official title: Xenon MRI in Pulmonary Hypertension
Run by Duke University · NCT04991454 · Data updated 2026-11-12
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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | September 1, 2021 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT04991454 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are outpatients aged 18-75 with a diagnosis of precapillary pulmonary hypertension awaiting lung transplantation.
✕Probably not a fit
Patients with moderate to severe heart disease or those not meeting the inclusion criteria will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to investigate the relationship between pulmonary vascular remodeling in pulmonary arterial hypertension (PAH) and changes in gas exchange physiology and hemodynamics using 129Xe MRI. The research involves two cohorts: the first will compare MRI signatures with lung pathology from patients awaiting lung transplants, while the second will assess the prognostic value of 129Xe MRI alongside standard clinical monitoring in PAH patients. The study seeks to correlate MRI findings with cellular changes and disease progression.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and monitoring of pulmonary hypertension, leading to improved patient outcomes.
How similar studies have gone: While the use of MRI in pulmonary hypertension is emerging, this specific approach using 129Xe MRI is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria of Cohort 1 Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Outpatients of either gender, Age 18-75 2. Awaiting a lung transplant 3. Diagnosis of precapillary PH (right heart catheterization demonstrating hemodynamic criteria of a mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, pulmonary vascular resistance ≥ 3 WU, pulmonary capillary wedge pressure ≤ 15 mmHg) in the setting of Group 1 (PAH), 3 (PH due to chronic lung disease, 4 (PH due to pulmonary artery obstructions), or 5 (PH due to miscellaneous causes) 4. Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed). 5. Women of childbearing potential must have a negative urine pregnancy test before MRI Exclusion Criteria of Cohort 1 Subjects presenting with any of the following will not be included in the trials: 1. Moderate to severe heart disease (LVEF \<45%, Severe LV hypertrophy, Moderate to severe valvular disease) 2. PH due to schistosomiasis 3. Active cancer 4. Sickle cell anemia 5. Prisoners and pregnant women will not be approached for the study 6. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine) 7. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements Inclusion Criteria of Cohort 2 Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Treatment naïve or treatment started within the last 3 months 2. Outpatients of either gender, Age 18-75 3. WHO functional class (FC) 2-3 symptoms with a diagnosis of group 1 PH (mean pulmonary artery pressures (mPAP) \> 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg and pulmonary vascular resistance (PVR) ≥3 WU) 4. Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed). 5. Women of childbearing potential must have a negative urine pregnancy test before MRI Exclusion Criteria of Cohort 2 Subjects presenting with any of the following will not be included in the trials: 1. Sarcoidosis 2. Active cancer 3. Sickle cell anemia 4. Liver disease (Childs-Pugh class C) 5. Any conditions that prevent the performance of 129Xe MRI scans. 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 subject or interfere with the subject's ability to comply with the protocol requirements
Where it's running
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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.
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Rutgers Genetics of Pulmonary Hypertension
This online project will try to see if genetic differences affect the risk of pulmonary hypertension in U.S. adults, and anyone 18 or older can join whether or not they have PH.
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Quality control of right heart catheterization for pulmonary vascular diseases in China
This study looks at the quality of right heart catheterization procedures for people with suspected pulmonary hypertension in China to see how well they are being done and what outcomes patients experience.
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129Xe MRI to monitor sotatercept treatment in pulmonary arterial hypertension
This will test whether hyperpolarized 129Xe MRI scans can noninvasively track lung blood-vessel improvement in adults with pulmonary arterial hypertension treated with sotatercept.
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Using artificial intelligence to evaluate pulmonary hypertension
This study is testing if using artificial intelligence with different medical tests can help doctors find pulmonary hypertension earlier and more accurately in patients.
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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
This study is testing a new device to see if it can safely help people with pulmonary hypertension and right heart problems feel better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.