Pulmonary Hypertension SOLAR
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBastiaan Driehuys
About this trial
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.
Eligibility criteria
Qualifiers
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
Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
Disqualifiers
Moderate to severe heart disease (LVEF < 45% or severe LV Hypertrophy).
Sarcoidosis.
Active cancer.
Sickle cell anemia.
Trial design
Treatments tested in this trial
- Hyperpolarized 129Xe
Treatment groups
30 Participants
are divided into 5 treatment groupsSponsors and collaborators
Bastiaan Driehuys
Lead sponsor
Duke University
Sponsor institution
Source ClinicalTrials.gov