The overall study objectives outlined in this study are to derive 129Xe MRI pulmonary vascular biomarker signatures that differentiate common subtypes of PAH and to determine the ability of 129Xe MRI to longitudinally monitor disease progression and response to therapy in PAH, with the aid of additional assessments, such as labs, echocardiography, and six-minute walk distance (6MWD).
Age: 18-75 years
WHO functional class 2 or 3
Mean pulmonary artery pressures > 20 mmHg
Pulmonary capillary wedge pressure ≤15 mmHg
PH other than Idiopathic PAH or PAH associated with CTD; any conditions that prevent the performance of 129Xe MRI scans will be excluded from the study.
Single group
129Xe Hyperpolarized
DrugEach xenon dose will be limited to a volume less than 25% of a subject's total lung capacity (TLC), as is the case for all protocols currently carried out under IND 109490
Pulmonary Vascular Remodeling
The primary endpoint for this trial will be the change in defect + low percentage of RBC signal on hyperpolarized 129Xe MRI from baseline to 12 months
RBC Oscillation Amplitude
• Change in regional and global RBC Oscillation Amplitudes on hyperpolarized 129Xe MR spectroscopy from baseline to 12 months
6 Minute Walk Distance
Change in 6MWD from baseline to month 12
NTproBNP
Change in NTproBNP from baseline to month 12
World Health Organization (WHO) Functional Class (FC)
Change in WHO FC from baseline to month 12
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Bastiaan Driehuys
Lead sponsor
Duke University
Sponsor institution
American Heart Association
Collaborator
