Trial Outcomes & Findings for Assessing Response to Inhaled Prostacyclin With Hyperpolarized Xe MRI (NCT NCT03367312)
NCT ID: NCT03367312
Last Updated: 2023-10-18
Results Overview
Percent change in pulmonary gas exchange (percent change in abnormal RBC percentage - calculated as: 100\*(value at 3 hours - value at baseline)/value at baseline) in patients with PH treated with inhaled prostacyclin.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
3 hours
Results posted on
2023-10-18
Participant Flow
Participant milestones
| Measure |
Pulmonary Hypertension Patients on Inhaled Prostacyclin
11 subjects will Pulmonary Hypertension on a stable dose of Inhaled Prostacyclin for treatment of PH.
Hyperpolarized 129Xenon gas: Hyperpolarized 129Xenon gas XeMRI scans will provide 3D images of ventilation and gas exchange pre, post, and 2-4 hours post inhaled prostacyclin treatment. Subjects will inhale HP 129Xe from the dose delivery bags with each scan and then move into the scanner and undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will undergo several MRI scans after inhalation of HPXe. This will occur as three scans at the three different time points (pre, post, and 2-4 hours post) of inhaled prostacyclin treatment.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing Response to Inhaled Prostacyclin With Hyperpolarized Xe MRI
Baseline characteristics by cohort
| Measure |
Pulmonary Hypertension Patients Treated With Inhaled Treprostinil (iTRE)
n=11 Participants
Patients with known PH on treatment with iTRE that are followed in the Duke Pulmonary Vascular Disease Clinic.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 hoursPercent change in pulmonary gas exchange (percent change in abnormal RBC percentage - calculated as: 100\*(value at 3 hours - value at baseline)/value at baseline) in patients with PH treated with inhaled prostacyclin.
Outcome measures
| Measure |
Pulmonary Hypertension Patients on Inhaled Prostacyclin
n=11 Participants
11 subjects will Pulmonary Hypertension on a stable dose of Inhaled Prostacyclin for treatment of PH.
Hyperpolarized 129Xenon gas: Hyperpolarized 129Xenon gas XeMRI scans will provide 3D images of ventilation and gas exchange pre, post, and 2-4 hours post inhaled prostacyclin treatment. Subjects will inhale HP 129Xe from the dose delivery bags with each scan and then move into the scanner and undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will undergo several MRI scans after inhalation of HPXe. This will occur as three scans at the three different time points (pre, post, and 2-4 hours post) of inhaled prostacyclin treatment.
|
|---|---|
|
Percent Change in Abnormal RBC Percentage
|
-17.7 percent change
Standard Deviation 24.4
|
Adverse Events
Pulmonary Hypertension Patients on Inhaled Prostacyclin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sudarshan Rajagopal
Duke University School of Medicine
Phone: 919-684-6237
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place