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Gas

Hyperpolarized 129Xenon gas for Pulmonary Vascular Disease

Phase 2
Waitlist Available
Led By Sudarshan Rajagopal, MD, PhD
Research Sponsored by Bastiaan Driehuys
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with known Pulmonary Hypertension on treatment with inhaled prostacyclin (iTRE) that are followed in the Duke Pulmonary Vascular Disease Clinic. Inclusion criteria includes: Group 1 PH (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg in the absence of significant concomitant left heart disease or lung disease), out-of-proportion Group 3 PH (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg with PVR ≥ 5 WU and evidence of right heart failure in the setting of lung disease), maintenance on a stable, well-tolerated treatment dose of iTRE (ideally ≥ 8 breaths QID)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 hours
Awards & highlights

Study Summary

This trial will use 129Xe MRI and other techniques to study how well the lungs are ventilated and how well they exchange gases.

Eligible Conditions
  • Pulmonary Vascular Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Patients with Pulmonary Hypertension who are on a treatment regimen of inhaled prostacyclin (iTRE) and are followed at the Duke Pulmonary Vascular Disease Clinic, meeting one or more of the following conditions: Group 1 PH (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg without significant concomitant left heart disease or lung disease), out-of-proportion Group 3 PH (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg with PVR ≥ 5 WU and evidence of right heart failure in the presence of lung disease), maintenance on a

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change in Abnormal RBC Percentage

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pulmonary Hypertension Patients on Inhaled ProstacyclinExperimental Treatment1 Intervention
10 subjects will Pulmonary Hypertension on a stable dose of Inhaled Prostacyclin for treatment of PH.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperpolarized 129Xenon gas
2018
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Bastiaan DriehuysLead Sponsor
13 Previous Clinical Trials
1,056 Total Patients Enrolled
1 Trials studying Pulmonary Vascular Disease
62 Patients Enrolled for Pulmonary Vascular Disease
United TherapeuticsIndustry Sponsor
107 Previous Clinical Trials
13,376 Total Patients Enrolled
Sudarshan Rajagopal, MD, PhDPrincipal InvestigatorDuke University
3 Previous Clinical Trials
105 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals are engaging in this medical experiment?

"Affirmative. Clinicaltrials.gov details that this investigation is currently enlisting participants, with the first posting on March 29th 2018 and last updated October 3rd 2022. The study seeks to enroll 12 individuals at a single research centre."

Answered by AI

Is this research the inaugural effort of its kind?

"Since 2018, Hyperpolarized 129Xenon gas has been under investigation. The initial trial occurred in that same year and was funded by United Therapeutics; after the 12-patient study finished Phase 2 trials, a single active clinical experiment is being sponsored by United Therpeutics."

Answered by AI

What other research studies have explored the use of Hyperpolarized 129Xenon gas?

"Currently, one active clinical trial exists for Hyperpolarized 129Xenon gas and none have reached Phase 3. This research is concentrated on Durham, North carolina but other medical centres are also participating in the study."

Answered by AI

What risks are associated with Hyperpolarized 129Xenon gas treatment?

"Assessed at a rating of 2 on the 1 to 3 scale, our team concluded that Hyperpolarized 129Xenon gas is relatively safe as Phase 2 clinical trials have yielded promising safety results but no efficacy data."

Answered by AI

Are there any remaining spots available for this research initiative?

"As attested by the clinicaltrials.gov website, this trial is actively enrolling participants. The study was first published on March 29th 2018 and underwent its most recent edit on October 3rd 2022."

Answered by AI
~2 spots leftby Mar 2025