Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04778046
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2021-02-26
Brief Title:
Pulmonary Hypertension SOLAR
Sponsor:
Bastiaan Driehuys
Organization:
Duke University
Study Overview
Official Title:
Defining a Noninvasive Signature for Pulmonary Vascular Remodeling in Group 3 PH
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PH SOLAR
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 signature may identify Group 3 PH responders to PAH-specific therapies PAHs 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
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 vascular fibrosis in IPF and COPD that could be used to identify potential responders vs non-responders to PAH-specific therapies The central hypothesis is that similar mechanisms and pathways underlie pulmonary vascular remodeling in IPF-PH COPD-PH and PAH However only a subset of Group 3 PH patients display remodeling consistent with PAH resulting in responder vs non-responder phenotypes when treated with PAH-specific therapies In preliminary studies of subjects treated with Tyvaso The study team has observed distinct 129Xe MRI signatures at baseline and with therapy depending on patients underlying lung function Consistent with this recent studies using single-cell RNA sequencing scRNAseq of the pulmonary vasculature in IPF have demonstrated changes consistent with vascular remodeling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None