Using 129Xe MRI to Diagnose and Monitor Pulmonary Arterial Hypertension
129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)
This study is testing if a special type of MRI can help doctors spot different types of Pulmonary Arterial Hypertension and track how the disease changes over time in people with this condition.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06104228 on ClinicalTrials.gov |
What this trial studies
This study aims to identify unique pulmonary vascular biomarker signatures using 129Xe MRI to differentiate subtypes of Pulmonary Arterial Hypertension (PAH) and to assess the ability of this imaging technique to monitor disease progression and response to therapy over time. A total of 20 subjects will be enrolled, with 10 having Idiopathic PAH and 10 with PAH associated with connective tissue disease. Participants will undergo 129Xe MRI scans at baseline, 3 months, 6 months, and 12 months, alongside standard assessments like echocardiography and six-minute walk distance. The primary endpoint focuses on changes in MRI signals over the study period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with either Idiopathic PAH or PAH associated with connective tissue disease, classified as WHO functional class 2 or 3.
Not a fit: Patients with pulmonary hypertension from causes other than Idiopathic PAH or PAH associated with connective tissue disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for diagnosing and monitoring treatment responses in patients with PAH.
How similar studies have performed: While the use of MRI in PAH is emerging, this specific approach using 129Xe MRI is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Fawaz Alenezi, MD — Duke Univeristy
- Study coordinator: Claudia Salazar
- Email: claudia.salazar@duke.edu
- Phone: +1 919 660 2026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.