Xenon MRI Pulm Hypertension

Launched by BASTIAAN DRIEHUYS · Jul 27, 2021

Keywords

ClinConnect Summary

This clinical trial, called "Xenon MRI Pulm Hypertension," is exploring how certain changes in the lungs and blood vessels impact breathing and heart function in patients with pulmonary hypertension (PH), particularly those with pulmonary arterial hypertension (PAH). The researchers are using a special type of MRI that involves xenon gas to see how these changes occur at both the cellular level and in overall body function, especially as the disease progresses or responds to treatment.

To participate in this study, you need to be an outpatient aged 18 to 75 who is waiting for a lung transplant or has recently started treatment for PH. You must also meet specific health criteria, such as having confirmed high blood pressure in the lungs. If selected, you can expect to undergo some tests, including the unique MRI scan. It's important to note that certain conditions, like severe heart disease or active cancer, would prevent you from joining this trial. Overall, this study aims to better understand pulmonary hypertension to improve future treatments.

Gender

ALL

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