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

Phase 2

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Xenon PAH Bio Trial 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.Check my eligibility

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.See study design

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.

Xenon PAH Bio Trial 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.

Xenon PAH Bio Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pulmonary Vascular Remodeling

Secondary outcome measures

6 Minute Walk Distance

NTproBNP

RBC Oscillation Amplitude

+1 more

Xenon PAH Bio 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Heart AssociationOTHER

326 Previous Clinical Trials

4,933,606 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial include individuals younger than 65 years of age?

"The eligibility criteria of this medical trial specifies that the minimum age to participate is 18, while the cut off for upper limit enrollment is 75."

Answered by AI

Is participation in this trial open to new volunteers?

"This clinical trial requires that applicants possess pulmonary arterial hypertension and must be aged between 18-75. A maximum of 20 individuals will be accepted into the program."

Answered by AI

What potential health risks is Idiopathic Pulmonary Arterial Hypertension associated with?

"Our team has rated the safety of Idiopathic Pulmonary Arterial Hypertension as a 2. This is because, although there is some data indicating its safety, this Phase 2 trial does not yet have information to vouch for efficacy."

Answered by AI

Does this trial currently provide openings for participants?

"According to the data found on clinicaltrials.gov, this trial is not actively recruiting patients; it was posted in January 2024 and last updated on October 2023. However, 867 other studies are currently enrolling participants for their trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)

Bastiaan Driehuys 2024. "129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06104228.

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