Pulmonary Arterial HypertensionPhase 2Xenon PAH BioNCT06104228
129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)
A Phase 2 study testing 129Xe Hyperpolarized in people with Pulmonary Arterial Hypertension and Idiopathic Pulmonary Arterial Hypertension, run by Bastiaan Driehuys at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Idiopathic Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension Associated With Connective Tissue Disease (Disorder)
- What is being tested?
- 129Xe Hyperpolarized
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2024to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
David Ptashnik, 9196682642, david.ptashnik@duke.edu
Fawaz A Alenezi, MD
About this study
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).
Read the detailed description
Subject Enrollment This study will consent and enroll 20 subjects total.
- For Arm 1, 10 subjects with Idiopathic Pulmonary Arterial Hypertension (IPAH) will be consented and enrolled. For Arm 2, 10 subjects with Connective Tissue Disease Associated Pulmonary Arterial Hypertension (PAH-CTD) will be consented and enrolled.
Study Design This study will be observational. Subjects in both arms of the trial will undergo a 129Xe MRI/MRS at timepoints of baseline, 3 months, 6 months, and 12 months. In addition to the this, data from standard of care assessments, such as labs, echocardiography, and six-minute walk distance (6MWD), will also collected at these timepoints.
Primary Study Endpoints The primary endpoint for this trial will be the change in defect + low percentage of RBC signal on hyperpolarized 129Xe MRI from baseline to 12 months
Secondary Study Endpoints
There will be several secondary endpoints for this trial:
- Change in regional and global RBC Oscillation Amplitudes on hyperpolarized 129Xe MR spectroscopy from baseline to 12 months
- Change in 6MWD from baseline to 12 months
- Change in NTproBNP from baseline to 12 months
- Change in WHO FC from baseline to 12 months
Primary Safety Endpoints
There will be several primary safety endpoints for this trial:
- Frequency of Adverse Events (AE) and/or Serious Adverse Events (SAE)
- Withdrawals due to adverse event or death
- Incidence of Adverse Events of Significant Interest (AESI):
- Electrocardiogram and any findings
- Physical examination and vital signs
- Conditions
- Pulmonary Arterial Hypertension, Idiopathic Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension Associated With Connective Tissue Disease (Disorder), Connective Tissue Diseases
- Being tested
- 129Xe Hyperpolarized
- Medical subject headings
- Pulmonary Arterial Hypertension, Familial Primary Pulmonary Hypertension, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
129Xe HyperpolarizedDrug
Each xenon dose will be limited to a volume less than 25% of a subject's total lung capacity (TLC), as is the case for all protocols currently carried out under IND 109490
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Pulmonary Arterial Hypertension | Other | Arm 1... patients with IPAH Receives: Drug: 129Xe Hyperpolarized |
| Pulmonary Arterial Hypertension Associated with Connective Tissue Disease | Other | Arm 2... patients with CTD-PAH Receives: Drug: 129Xe Hyperpolarized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Vascular Remodeling
The primary endpoint for this trial will be the change in defect + low percentage of RBC signal on hyperpolarized 129Xe MRI from baseline to 12 months
Measured: 1 year
Secondary outcomes (4)
RBC Oscillation Amplitude
- Change in regional and global RBC Oscillation Amplitudes on hyperpolarized 129Xe MR spectroscopy from baseline to 12 months
Measured: 1 year
6 Minute Walk Distance
Change in 6MWD from baseline to month 12
Measured: 1 Year
NTproBNP
Change in NTproBNP from baseline to month 12
Measured: 1 year
World Health Organization (WHO) Functional Class (FC)
Change in WHO FC from baseline to month 12
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start12 Aug 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bastiaan Driehuys
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor-investigator, Bastiaan Driehuys, Duke University
- Investigators
- Fawaz Alenezi, MD, Principal investigator, Duke Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104228
- Sponsor's protocol ID
- Pro00113893
- Acronym
- Xenon PAH Bio
- Status last verified
- Feb 2026
- First submitted
- 23 Oct 2023
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)
- ClinicalTrials.gov ID
- NCT06104228
- Acronym / sponsor ID
- Xenon PAH Bio / Pro00113893
- Conditions
- Pulmonary Arterial Hypertension, Idiopathic Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension Associated With Connective Tissue Disease (Disorder), Connective Tissue Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bastiaan DriehuysUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Subject Enrollment This study will consent and enroll 20 subjects total.
- For Arm 1, 10 subjects with Idiopathic Pulmonary Arterial Hypertension (IPAH) will be consented and enrolled. For Arm 2, 10 subjects with Connective Tissue Disease Associated Pulmonary Arterial Hypertension (PAH-CTD) will be consented and enrolled.
Study Design This study will be observational. Subjects in both arms of the trial will undergo a 129Xe MRI/MRS at timepoints of baseline, 3 months, 6 months, and 12 months. In addition to the this, data from standard of care assessments, such as labs, echocardiography, and six-minute walk distance (6MWD), will also collected at these timepoints.
Primary Study Endpoints The primary endpoint for this trial will be the change in defect + low percentage of RBC signal on hyperpolarized 129Xe MRI from baseline to 12 months
Secondary Study Endpoints
There will be several secondary endpoints for this trial:
- Change in regional and global RBC Oscillation Amplitudes on hyperpolarized 129Xe MR spectroscopy from baseline to 12 months
- Change in 6MWD from baseline to 12 months
- Change in NTproBNP from baseline to 12 months
- Change in WHO FC from baseline to 12 months
Primary Safety Endpoints
There will be several primary safety endpoints for this trial:
- Frequency of Adverse Events (AE) and/or Serious Adverse Events (SAE)
- Withdrawals due to adverse event or death
- Incidence of Adverse Events of Significant Interest (AESI):
- Electrocardiogram and any findings
- Physical examination and vital signs
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Pulmonary Arterial Hypertension | Other | Drug: 129Xe HyperpolarizedArm 1... patients with IPAH |
| Pulmonary Arterial Hypertension Associated with Connective Tissue Disease | Other | Drug: 129Xe HyperpolarizedArm 2... patients with CTD-PAH |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 129Xe HyperpolarizedEach xenon dose will be limited to a volume less than 25% of a subject's total lung capacity (TLC), as is the case for all protocols currently carried out under IND 109490 | Drug | Idiopathic Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension Associated with Connective Tissue Disease |
Primary outcome
Pulmonary Vascular Remodeling
Time frame: 1 year
The primary endpoint for this trial will be the change in defect + low percentage of RBC signal on hyperpolarized 129Xe MRI from baseline to 12 months
4 secondary outcomes
RBC Oscillation Amplitude
Time frame: 1 year
6 Minute Walk Distance
Time frame: 1 Year
NTproBNP
Time frame: 1 year
World Health Organization (WHO) Functional Class (FC)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fawaz Alenezi, MD principal investigator
Duke Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 129Xe Hyperpolarized in people with Pulmonary Arterial Hypertension and Idiopathic Pulmonary Arterial Hypertension, run by Bastiaan Driehuys at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Salazar (+1 919 660 2026, claudia.salazar@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Vascular Remodeling (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.