Pulmonary Hypertension SOLAR
NCT04778046 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-02-24
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.
Conditions
Interventions
- DRUG
-
Hyperpolarized 129Xe
Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),
Sponsors & Collaborators
-
Bastiaan Driehuys
lead OTHER
Principal Investigators
-
Sudarshan Rajagopal, MD, PhD · Duke University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-08
- Primary Completion
- 2027-07-31
- Completion
- 2028-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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