NCT06104228 129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)
| NCT ID | NCT06104228 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Bastiaan Driehuys |
| Condition | Pulmonary Arterial Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-08-12 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-08-12 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Fawaz Alenezi, MD
PRINCIPAL INVESTIGATOR
Duke Univeristy
Frequently Asked Questions
Who can join the NCT06104228 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pulmonary Arterial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06104228 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06104228 currently recruiting?
Yes, NCT06104228 is actively recruiting participants. Contact the research team at claudia.salazar@duke.edu for enrollment information.
Where is the NCT06104228 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06104228 clinical trial?
NCT06104228 is sponsored by Bastiaan Driehuys. The principal investigator is Fawaz Alenezi, MD at Duke Univeristy. The trial plans to enroll 20 participants.