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RECRUITINGPhase 2INTERVENTIONAL

Xenon MRI Pulm Hypertension

Xenon MRI in Pulmonary Hypertension

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

129Xe 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.

Locations (1)

Duke University Medical Center
Durham, North Carolina, United States