Status:
RECRUITING
Pulmonary Hypertension SOLAR
Lead Sponsor:
Bastiaan Driehuys
Conditions:
Interstitial Lung Disease
COPD
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 si...
Detailed Description
The objective of this study is to identify a 129Xe MRI signature associated with PAH-like pulmonary vascular remodeling, consisting of plexiform arteriopathy, smooth muscle cell proliferation, and vas...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04778046
Start Date
November 8 2023
End Date
December 30 2025
Last Update
October 21 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710