129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)
Recruiting · NCT06104228 · Interventional (participants receive a specific treatment) · Lead sponsor: Bastiaan Driehuys
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Duke University Medical Center - Durham, North Carolina, United States