Home › Pulmonary Hypertension › NCT04991454
Xenon MRI Pulm Hypertension
RecruitingPhase 2
Xenon MRI in Pulmonary Hypertension
Who can join
Ages 18 to 75 · All sexes
Full eligibility 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
About the study
The overall objective outlined in this study is to determine how pulmonary vascular remodeling in PAH at a cellular and pathological level is associated with changes in gas exchange physiology and hemodynamics (monitored with 129Xe MRI/MRS) and how these signals change with disease progression or treatment.
What is being tested
- 129Xe Hyperpolarized (drug)
Sponsor: Bastiaan Driehuys · Participants: 20 · Started: Sep 1, 2021
Contact the study team
- Claudia Salazar · Phone: +1 919 660 2026
Official record on ClinicalTrials.gov — NCT04991454
Locations in the U.S.
| North Carolina | Duke University Medical Center, Durham |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.