Pulmonary Artery HypertensionPhase 2NCT06122922
Xenon MRI in Stable Pulmonary Hypertension (Jupiter AUGEAN)
A Phase 2 study testing Hyperpolarized Xe129 in people with Pulmonary Artery Hypertension, run by Bastiaan Driehuys.
Trial summary
The objective of this project is to determine how pulmonary vascular remodeling in Pulmonary Arterial Hypertension (PAH) at cellular and pathological level is associated with gas exchange physiology changes and hemodynamics (monitored with 129Xe MRI/MRS) and how these signals change with disease progression or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Artery Hypertension
- What is being tested?
- Hyperpolarized Xe129
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Stable on current treatment regimen and not planning to undergo initiation of new therapy for at least 3 months
- Outpatients of any gender, Age 18-75
- WHO functional class (FC) 1-3 symptoms with a diagnosis of group 1 PH (mean pulmonary artery pressures (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg and pulmonary vascular resistance (PVR) ≥3 WU)
- Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
- Women of childbearing potential must have a negative urine pregnancy test before MRI
Who cannot join
- Sarcoidosis
- Active cancer
- Sickle cell anemia
- Liver disease (Childs-Pugh class C)
- Any conditions that prevent the performance of 129Xe MRI scans.
- Prisoners and pregnant women will not be approached for the study
- Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
- Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
About this study
Official title: Xenon MRI in Stable Patients With Pulmonary Hypertension
The objective of this project is to determine how pulmonary vascular remodeling in Pulmonary Arterial Hypertension (PAH) at cellular and pathological level is associated with gas exchange physiology changes and hemodynamics (monitored with 129Xe MRI/MRS) and how these signals change with disease progression or treatment.
Read the detailed description
The clinical and research need for noninvasive biomarkers in pulmonary arterial hypertension (PAH) has led the study team to develop 129Xe magnetic resonance imaging (129Xe MRI) to image pulmonary vascular pathology through quantitative 3D maps of gas transfer across the pulmonary blood-gas barrier. 129Xe MRI, in combination with 129Xe spectroscopy (MRS), has a unique signature in PAH and can simultaneously measure capillary blood volume and hemodynamic changes associated with pulmonary vascular remodeling (Wang '19a). This project aims to determine how pulmonary vascular remodeling in PAH at a cellular and pathological level is related to gas exchange physiology changes and hemodynamics (monitored with 129Xe MRI/MRS) and the change in these signals over one year in patients with "stable" PAH. Our central hypothesis is that patients with "stable" PAH will display persistent abnormalities on 129Xe MRI/MRS consistent with pulmonary vascular remodeling and that some patients may have worsening of their disease while appearing to be "stable" disease.
The study team will assess the ability of 129Xe MRI to longitudinally monitor disease progression in patients with "stable" PAH. First, the team will enroll "stable" PAH patients and obtain detailed clinical information to be stored in the REDCAP database. The study team will then follow this cohort of PAH subjects for one year, performing 129Xe MRI scans at baseline, 3 months, 6 months and one year in addition to their standard-of-care assessments including appointments labs, echo, and 6MWTs.
- Conditions
- Pulmonary Artery Hypertension
- Being tested
- Hyperpolarized Xe129
- Medical subject headings
- Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Xe129Drug
Hyperpolarized Xenon Gas
| Study group | Role | What they receive |
|---|---|---|
| Patients with Stable Pulmonary Arterial Hypertension | Other | Stable on current treatment regimen and not planning to undergo initiation of new therapy for at least 3 months Intervention: Drug: 129Xe Hyperpolarized Receives: Drug: Hyperpolarized Xe129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary vascular function
Measured by RBC/Membrane metrics on Xe MRI
Measured: Baseline, 3 months, 6 months, 1 year
Change in pulmonary vascular function
Measured by RBC shift metrics on Xe MRI
Measured: Baseline, 3 months, 6 months, 1 year
Change in pulmonary vascular functoin
Measured by RBC amplitude oscillation metrics on Xe MRI
Measured: Baseline, 3 months, 6 months, 1 year
Secondary outcomes (4)
Six Minute Walk Test Distance (6MWD)
Distance patient is able to walk during a six minute walk test
Measured: Baseline, 3 months, 6 months, 1 year
NTproBNP
Lab value of NTproBNP
Measured: Baseline, 3 months, 6 months, 1 year
World Health Organization (WHO) Functional Class (FC)
Change in Functional Class of Pulmonary Hypertension symptoms
Measured: Baseline, 3 months, 6 months, 1 year
Hopsitalizations
Frequency of hospitalizations
Measured: Baseline, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start15 Mar 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Artery 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastiaan Driehuys
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor-investigator, Bastiaan Driehuys, Duke University
- Investigators
- Sudarshan Rajagopal, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122922
- Sponsor's protocol ID
- Pro00113235
- Status last verified
- Jan 2024
- First submitted
- 3 Nov 2023
- Last updated
- 23 Jan 2024
- 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 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xenon MRI in Stable Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06122922
- Acronym / sponsor ID
- Pro00113235
- Conditions
- Pulmonary Artery Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bastiaan DriehuysUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Nov 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 objective of this project is to determine how pulmonary vascular remodeling in Pulmonary Arterial Hypertension (PAH) at cellular and pathological level is associated with gas exchange physiology changes and hemodynamics (monitored with 129Xe MRI/MRS) and how these signals change with disease progression or treatment.
Detailed description
The clinical and research need for noninvasive biomarkers in pulmonary arterial hypertension (PAH) has led the study team to develop 129Xe magnetic resonance imaging (129Xe MRI) to image pulmonary vascular pathology through quantitative 3D maps of gas transfer across the pulmonary blood-gas barrier. 129Xe MRI, in combination with 129Xe spectroscopy (MRS), has a unique signature in PAH and can simultaneously measure capillary blood volume and hemodynamic changes associated with pulmonary vascular remodeling (Wang '19a). This project aims to determine how pulmonary vascular remodeling in PAH at a cellular and pathological level is related to gas exchange physiology changes and hemodynamics (monitored with 129Xe MRI/MRS) and the change in these signals over one year in patients with "stable" PAH. Our central hypothesis is that patients with "stable" PAH will display persistent abnormalities on 129Xe MRI/MRS consistent with pulmonary vascular remodeling and that some patients may have worsening of their disease while appearing to be "stable" disease.
The study team will assess the ability of 129Xe MRI to longitudinally monitor disease progression in patients with "stable" PAH. First, the team will enroll "stable" PAH patients and obtain detailed clinical information to be stored in the REDCAP database. The study team will then follow this cohort of PAH subjects for one year, performing 129Xe MRI scans at baseline, 3 months, 6 months and one year in addition to their standard-of-care assessments including appointments labs, echo, and 6MWTs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Stable Pulmonary Arterial Hypertension | Other | Drug: Hyperpolarized Xe129Stable on current treatment regimen and not planning to undergo initiation of new therapy for at least 3 months Intervention: Drug: 129Xe Hyperpolarized |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stable on current treatment regimen and not planning to undergo initiation of new therapy for at least 3 months
- Outpatients of any gender, Age 18-75
- WHO functional class (FC) 1-3 symptoms with a diagnosis of group 1 PH (mean pulmonary artery pressures (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg and pulmonary vascular resistance (PVR) ≥3 WU)
- Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
- Women of childbearing potential must have a negative urine pregnancy test before MRI
Key exclusion criteria (8 listed)
- Sarcoidosis
- Active cancer
- Sickle cell anemia
- Liver disease (Childs-Pugh class C)
- Any conditions that prevent the performance of 129Xe MRI scans.
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 |
|---|---|---|
| Hyperpolarized Xe129Hyperpolarized Xenon Gas | Drug | Patients with Stable Pulmonary Arterial Hypertension |
Primary outcome
Change in pulmonary vascular function
Time frame: Baseline, 3 months, 6 months, 1 year
Measured by RBC/Membrane metrics on Xe MRI
Change in pulmonary vascular function
Time frame: Baseline, 3 months, 6 months, 1 year
Measured by RBC shift metrics on Xe MRI
Change in pulmonary vascular functoin
Time frame: Baseline, 3 months, 6 months, 1 year
Measured by RBC amplitude oscillation metrics on Xe MRI
4 secondary outcomes
Six Minute Walk Test Distance (6MWD)
Time frame: Baseline, 3 months, 6 months, 1 year
NTproBNP
Time frame: Baseline, 3 months, 6 months, 1 year
World Health Organization (WHO) Functional Class (FC)
Time frame: Baseline, 3 months, 6 months, 1 year
Hopsitalizations
Time frame: Baseline, 3 months, 6 months, 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- 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. This study is not recruiting at the moment.
Sudarshan Rajagopal, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperpolarized Xe129 in people with Pulmonary Artery Hypertension, run by Bastiaan Driehuys.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulmonary vascular function (time frame: Baseline, 3 months, 6 months, 1 year). The study lists 3 primary outcomes in all. 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 23 Jan 2024.