Status:
COMPLETED
Assessing Response to Inhaled Prostacyclin With Hyperpolarized Xe MRI
Lead Sponsor:
Bastiaan Driehuys
Collaborating Sponsors:
United Therapeutics
Conditions:
Pulmonary Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study seeks to deploy several forms of 129Xe MRI contrast as well as emerging conventional proton MRI techniques for imaging lung structure and perfusion. Specifically, the 129Xe MRI scans will p...
Detailed Description
This study seeks to determine whether hyperpolarized 129Xenon MRI can detect improvements in pulmonary gas exchange in patients with Group 1 and 3 PH treated with iTRE. We will associate this with cha...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with known Pulmonary Hypertension on treatment with inhaled prostacyclin (iTRE) that are followed in the Duke Pulmonary Vascular Disease Clinic. Inclusion criteria includes: Group 1 PH (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg in the absence of significant concomitant left heart disease or lung disease), out-of-proportion Group 3 PH (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg with PVR ≥ 5 WU and evidence of right heart failure in the setting of lung disease), maintenance on a stable, well-tolerated treatment dose of iTRE (ideally ≥ 8 breaths QID)
- Exclusion criteria:
- Pregnant women were excluded from this study. Women of childbearing potential must have a negative urine pregnancy test in order to participate in this study.
- Definition of Women of CBP: The median age of menopause in the US, defined as 12 months of amenorrhea, is 51 years; by age 48, approximately 15% of women will be postmenopausal, while virtually 100% will be post-menopausal by age 53. Women are considered past the age of "child-bearing potential" if
- they are greater than 55 years of age, OR
- they are at least 50 years of age AND o have not menstruated for at least 12 months, OR
- have a documented Follicule Stimulating Hormone (FSH) level of greater than 40 mIU/mL.
- they are at least 45 years of age AND o have not menstruated for at least 18 months, OR
- have a documented Follicule Stimulating Hormone (FSH) level of greater than 40 mIU/mL.
Exclusion
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03367312
Start Date
March 29 2018
End Date
November 1 2022
Last Update
October 18 2023
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710