RecruitingPhase 2NCT04991454

Xenon MRI Pulm Hypertension

Xenon MRI in Pulmonary Hypertension

Sponsor

Bastiaan Driehuys

Enrollment

60 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

Pulmonary Hypertension Pulmonary Arterial Hypertension

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria10

Outpatients of either gender, Age 18-75
Awaiting a lung transplant
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)
Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
Women of childbearing potential must have a negative urine pregnancy test before MRI
Treatment naïve or treatment started within the last 3 months
Outpatients of either gender, Age 18-75
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)
Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
Women of childbearing potential must have a negative urine pregnancy test before MRI

Exclusion Criteria17

Subjects presenting with any of the following will not be included in the trials:
Moderate to severe heart disease (LVEF \<45%, Severe LV hypertrophy, Moderate to severe valvular disease)
PH due to schistosomiasis
Active cancer
Sickle cell anemia
Prisoners and pregnant women will not be approached for the study
Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
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
Subjects presenting with any of the following will not be included in the trials:
Sarcoidosis
Active cancer
Sickle cell anemia
Liver disease (Childs-Pugh class C)
Any conditions that prevent the performance of 129Xe MRI scans.
Prisoners and pregnant women will not be approached for the study.
Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).
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

Interventions

DRUG129Xe Hyperpolarized

Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC), as is the case for all protocols currently carried out under IND 109,490.