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129 Xenon MRI for Pulmonary Arterial Hypertension (Xenon PAH Bio Trial)

Phase 2
Recruiting
Led By Fawaz Alenezi, MD
Research Sponsored by Bastiaan Driehuys
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Arm 1 - IPAH: No other cause identified for PAH
Arm 1 - IPAH: WHO functional class 2 or 3
Must not have
PH other than Idiopathic PAH or PAH associated with CTD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to use MRI to create biomarkers for pulmonary arterial hypertension & track disease progression & response to therapy.

Who is the study for?
This trial is for adults aged 18-75 with Pulmonary Arterial Hypertension (PAH), either idiopathic or associated with connective tissue disease. Participants must have specific heart and lung pressure measurements, be in WHO functional class 2 or 3, and not have other causes for PAH. Those unable to undergo a 129Xe MRI scan or with different types of pulmonary hypertension are excluded.
What is being tested?
The study tests the use of a special type of MRI scan using hyperpolarized Xenon gas (129Xe) as a way to identify different subtypes of PAH and monitor changes over time in response to treatment. It will be used alongside other assessments like blood tests, echocardiograms, and walking distance measures.
What are the potential side effects?
While the description does not specify side effects related to the intervention directly, typical MRI-related side effects could include discomfort from lying still during the procedure or noise during scanning. The use of hyperpolarized Xenon should be safe but may carry minimal risks which will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My pulmonary arterial hypertension has no other identified cause.
Select...
I have IPAH and my symptoms are moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My pulmonary hypertension is not caused by idiopathic PAH or connective tissue disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pulmonary Vascular Remodeling
Secondary study objectives
6 Minute Walk Distance
NTproBNP
RBC Oscillation Amplitude
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pulmonary Arterial Hypertension Associated with Connective Tissue DiseaseExperimental Treatment1 Intervention
Arm 2... patients with CTD-PAH
Group II: Idiopathic Pulmonary Arterial HypertensionExperimental Treatment1 Intervention
Arm 1... patients with IPAH

Find a Location

Who is running the clinical trial?

American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,472 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
22 Patients Enrolled for Pulmonary Arterial Hypertension
Bastiaan DriehuysLead Sponsor
14 Previous Clinical Trials
1,061 Total Patients Enrolled
4 Trials studying Pulmonary Arterial Hypertension
104 Patients Enrolled for Pulmonary Arterial Hypertension
Fawaz Alenezi, MDPrincipal InvestigatorDuke Univeristy
~13 spots leftby Jan 2026
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