Using Xenon MRI to study pulmonary hypertension

Xenon MRI in 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.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Duke University (Academic / other)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT04991454 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are outpatients aged 18-75 with a diagnosis of precapillary pulmonary hypertension awaiting lung transplantation.

Not a fit: Patients with moderate to severe heart disease or those not meeting the inclusion criteria will not benefit from this study.

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 performed: 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.

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

Where this trial is running

Durham, North Carolina

• Duke University Medical Center — Durham, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Sudarshan Rajagopal, MD, PhD — Duke University
• Study coordinator: David Ptashnik, MS

Conditions Pulmonary Hypertension; Pulmonary Arterial Hypertension; Lung Transplant; Xenon; MRI