Pulmonary Hypertension SOLAR (NCT04778046) | Clinical Trial Compass
RecruitingPhase 2
Pulmonary Hypertension SOLAR
United States30 participantsStarted 2023-11-08
Plain-language summary
The main goal of this study is to develop a noninvasive signature for pulmonary vascular remodeling in Group 3 PH patients, using hyperpolarized 129Xe magnetic resonance imaging (129Xe MRI). Such a signature may identify Group 3 PH responders to PAH-specific therapies. PAH's unique 129Xe MRI signature has been shown in previous studies. Past studies have lacked a pathologic "ground truth" correlate of these signatures, which could be provided by comparing them with the pathology of lung explant tissue from patients who have undergone a lung transplant. This signature could be validated in a cohort of patients with Group 3 PH in future studies.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years' old
✓. Be on the lung transplant waiting list at Duke University Medical Center.
✓. PH as defined by RHC - mPAP \> 20 mmHg, PVR \> 3 WU, PCWP \< 15 mmHg
✓. Groups defined as:
✓. Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
Exclusion criteria
✕. Moderate to severe heart disease (LVEF \< 45% or severe LV Hypertrophy).
✕. Sarcoidosis.
✕. Active cancer.
✕. Sickle cell anemia.
✕. Liver disease (Childs-Pugh class C).
✕. Prisoners and pregnant women will not be approached for the study.
What they're measuring
1
a pathology-based 129Xe MRI noninvasive signature of pulmonary vascular remodeling that could be validated in a larger cohort of Group 3 PH patients