Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06104228
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2023-10-23
Brief Title:
129 Xenon MRI As a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension PAH
Sponsor:
Bastiaan Driehuys
Organization:
Duke University
Study Overview
Official Title:
129 Xenon MRI As a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension PAH
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:
Xenon PAH Bio
Brief Summary:
The overall study objectives outlined in this study are to derive 129Xe MRI pulmonary vascular biomarker signatures that differentiate common subtypes of PAH and to determine the ability of 129Xe MRI to longitudinally monitor disease progression and response to therapy in PAH with the aid of additional assessments such as labs echocardiography and six-minute walk distance 6MWD
Detailed Description:
Subject Enrollment This study will consent and enroll 20 subjects total
For Arm 1 10 subjects with Idiopathic Pulmonary Arterial Hypertension IPAH will be consented and enrolled For Arm 2 10 subjects with Connective Tissue Disease Associated Pulmonary Arterial Hypertension PAH-CTD will be consented and enrolled
Study Design This study will be observational Subjects in both arms of the trial will undergo a 129Xe MRIMRS at timepoints of baseline 3 months 6 months and 12 months In addition to the this data from standard of care assessments such as labs echocardiography and six-minute walk distance 6MWD will also collected at these timepoints
Primary Study Endpoints The primary endpoint for this trial will be the change in defect low percentage of RBC signal on hyperpolarized 129Xe MRI from baseline to 12 months
Secondary Study Endpoints
There will be several secondary endpoints for this trial
Change in regional and global RBC Oscillation Amplitudes on hyperpolarized 129Xe MR spectroscopy from baseline to 12 months
Change in 6MWD from baseline to 12 months
Change in NTproBNP from baseline to 12 months
Change in WHO FC from baseline to 12 months
Primary Safety Endpoints
There will be several primary safety endpoints for this trial
Frequency of Adverse Events AE andor Serious Adverse Events SAE
Withdrawals due to adverse event or death
Incidence of Adverse Events of Significant Interest AESI
Electrocardiogram and any findings
Physical examination and vital signs
For Arm 1 10 subjects with Idiopathic Pulmonary Arterial Hypertension IPAH will be consented and enrolled For Arm 2 10 subjects with Connective Tissue Disease Associated Pulmonary Arterial Hypertension PAH-CTD will be consented and enrolled
Study Design This study will be observational Subjects in both arms of the trial will undergo a 129Xe MRIMRS at timepoints of baseline 3 months 6 months and 12 months In addition to the this data from standard of care assessments such as labs echocardiography and six-minute walk distance 6MWD will also collected at these timepoints
Primary Study Endpoints The primary endpoint for this trial will be the change in defect low percentage of RBC signal on hyperpolarized 129Xe MRI from baseline to 12 months
Secondary Study Endpoints
There will be several secondary endpoints for this trial
Change in regional and global RBC Oscillation Amplitudes on hyperpolarized 129Xe MR spectroscopy from baseline to 12 months
Change in 6MWD from baseline to 12 months
Change in NTproBNP from baseline to 12 months
Change in WHO FC from baseline to 12 months
Primary Safety Endpoints
There will be several primary safety endpoints for this trial
Frequency of Adverse Events AE andor Serious Adverse Events SAE
Withdrawals due to adverse event or death
Incidence of Adverse Events of Significant Interest AESI
Electrocardiogram and any findings
Physical examination and vital signs
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