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Pulmonary Hypertension SOLAR
Defining a Noninvasive Signature for Pulmonary Vascular Remodeling in Group 3 PH
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Age ≥ 18 years' old 2. Be on the lung transplant waiting list at Duke University Medical Center. 3. PH as defined by RHC - mPAP \> 20 mmHg, PVR \> 3 WU, PCWP \< 15 mmHg 4. Groups defined as: PAH: Clinical diagnosis of PAH (Group 1 PH) in the absence of severe chronic lung disease, left heart disease, chronic thromboembolism, sarcoidosis, sickle cell disease, or other causes of non-Group 1 PH. COPD-noPH: Clinical diagnosis of COPD in the absence of precapillary PH. COPD-PH: Clinical diagnosis of COPD with precapillary PH. IPF-noPH: Clinical diagnosis of IPF in the absence of precapillary PH. IPF-PH: Clinical diagnosis of IPF with precapillary PH. 5. 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: 1. Moderate to severe heart disease (LVEF \< 45% or severe LV Hypertrophy). 2. Sarcoidosis. 3. Active cancer. 4. Sickle cell anemia. 5. Liver disease (Childs-Pugh class C). 6. Prisoners and pregnant women will not be approached for the study. 7. Inability to obtain consent. 8. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine). 9. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
About the study
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.
What is being tested
- Hyperpolarized 129Xe (drug)
Sponsor: Bastiaan Driehuys · Participants: 30 · Started: Nov 8, 2023
Contact the study team
- Claudia Salazar · Phone: +1 919 660 2026
Official record on ClinicalTrials.gov — NCT04778046
Locations in the U.S.
| North Carolina | Duke University Medical Center, Durham |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.