RECRUITINGPhase 2INTERVENTIONAL
129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
Arm 1 -IPAH
- Age: 18-75 years
- WHO functional class 2 or 3
- Mean pulmonary artery pressures \> 20 mmHg
- Pulmonary capillary wedge pressure ≤15 mmHg
- Pulmonary vascular resistance \> 2 Wood Units (WU)
- No other cause identified for PAH
Arm 2 -PAH-CTD
- Age: 18-75 years
- WHO functional class (FC) 2 or 3
- Mean pulmonary artery pressures \> 20 mmHg
- Pulmonary capillary wedge pressure ≤15 mmHg
- Pulmonary vascular resistance \> 2 WU
- Diagnosis of connective tissue disease
Who Should NOT Join This Trial:
- PH other than Idiopathic PAH or PAH associated with CTD; any conditions that prevent the performance of 129Xe MRI scans will be excluded from the study.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
Arm 1 -IPAH
* Age: 18-75 years
* WHO functional class 2 or 3
* Mean pulmonary artery pressures \> 20 mmHg
* Pulmonary capillary wedge pressure ≤15 mmHg
* Pulmonary vascular resistance \> 2 Wood Units (WU)
* No other cause identified for PAH
Arm 2 -PAH-CTD
* Age: 18-75 years
* WHO functional class (FC) 2 or 3
* Mean pulmonary artery pressures \> 20 mmHg
* Pulmonary capillary wedge pressure ≤15 mmHg
* Pulmonary vascular resistance \> 2 WU
* Diagnosis of connective tissue disease
Exclusion Criteria:
* PH other than Idiopathic PAH or PAH associated with CTD; any conditions that prevent the performance of 129Xe MRI scans will be excluded from the study.
Treatments Being Tested
DRUG
129Xe Hyperpolarized
Each xenon dose will be limited to a volume less than 25% of a subject's total lung capacity (TLC), as is the case for all protocols currently carried out under IND 109490
Locations (1)
Duke University Medical Center
Durham, North Carolina, United States