Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03367312 | Assessing Response to Inhaled Prostacyclin With Hyperpolarized Xe MRI | PHASE2 | COMPLETED | 11 | — | — | Mar 29, 2018 | Nov 1, 2022 | Oct 18, 2023 | 1 | United States |
Percent change in pulmonary gas exchange (percent change in abnormal RBC percentage - calculated as: 100\*(value at 3 hours - value at baseline)/value at baseline) in patients with PH treated with inhaled prostacyclin.
| Arm | Type | Description |
|---|---|---|
| Pulmonary Hypertension Patients on Inhaled Prostacyclin | EXPERIMENTAL | 10 subjects will Pulmonary Hypertension on a stable dose of Inhaled Prostacyclin for treatment of PH. |
| Name | Type | Description |
|---|---|---|
| Hyperpolarized 129Xenon gas | DRUG | Hyperpolarized 129Xenon gas XeMRI scans will provide 3D images of ventilation and gas exchange pre, post, and 2-4 hours post inhaled prostacyclin treatment. Subjects will inhale HP 129Xe from the dose delivery bags with each scan and then move into the scanner and undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will undergo several MRI scans after inhalation of HPXe. This will occur as three scans at the three different time points (pre, post, and 2-4 hours post) of inhaled prostacyclin treatment. |
Inclusion Criteria: Patients with known Pulmonary Hypertension on treatment with inhaled prostacyclin (iTRE) that are followed in the Duke Pulmonary Vascular Disease Clinic. Inclusion criteria includes: Group 1 PH (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg in the absence of significant concomitant left heart ...