Pulmonary Hypertension SOLAR
Recruiting now · Phase 2
Conditions studied: Interstitial Lung Disease, COPD, Pulmonary Arterial Hypertension
In brief
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.
Key facts
- Study ID
- NCT04778046
- Run by
- Bastiaan Driehuys
- People needed
- 30
- Starts
- 2023-11-08
- Expected to finish
- 2028-07-31
- Last updated by the study team
- 2026-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- 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.
- Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
You may not qualify if…
- 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.
- Inability to obtain consent.
- Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).
- 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
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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