Bastiaan Driehuys
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).
Subject Enrollment This study will consent and enroll 20 subjects total. • For Arm 1, 10 subjects with Idiopathic Pulmonary Arterial Hypertension (IPAH) will be consented and enrolled. For Arm 2, 10 subjects with Connective Tissue Disease Associated Pulmonary Arterial Hypertension (PAH-CTD) will be consented and enrolled. Study Design This study will be observational. Subjects in both arms of the trial will undergo a 129Xe MRI/MRS at timepoints of baseline, 3 months, 6 months, and 12 months. In addition to the this, data from standard of care assessments, such as labs, echocardiography, and…
Inclusion Criteria: Arm 1 -IPAH * Age: 18-75 years * WHO functional class 2 or 3 * Mean pulmonary artery pressures \> 20 mmHg * Pulmonary capillary wedge pressure ≤15 mmHg * Pulmonary vascular resistance \> 2 Wood Units (WU) * No other cause identified for PAH Arm 2 -PAH-CTD * Age: 18-75 years * WHO functional class (FC) 2 or 3 * Mean pulmonary artery pressures \> 20 mmHg * Pulmonary capillary wedge pressure ≤15 mmHg * Pulmonary vascular resistance \> 2 WU * Diagnosis of connective tissue disease Exclusion Criteria: * PH other than Idiopathic PAH or PAH associated with CTD; any condition…
Each 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
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