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New treatment option for Pulmonary Hypertension
Official title 129 Xenon Imaging in Patients Treated With Sotatercept
ClinicalTrials.gov ID: NCT06351345
What this study is testing
What is 129Xe Hyperpolarized?
129Xe Hyperpolarized is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for pulmonary hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Determine the ability of 129Xe MRI/MRS biomarker signatures to non-invasively monitor pulmonary vascular reverse remodeling induced by sotatercept in pulmonary arterial hypertension (PAH).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Outpatients of either gender, Age 18-75
- Diagnosis of precapillary PH (right heart catheterization demonstrating hemodynamic criteria of a mean pulmonary artery pressure (mPAP) ≥ 20 mmHg...
- Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
- On a stable dose of background PAH therapy for \> 90 days prior to study enrollment
- Women of childbearing potential must have a negative urine pregnancy test before MRI
You likely can't join if
- Moderate to severe heart disease (LVEF \< 45%, Severe LV hypertrophy, Moderate to severe valvular disease)
- Chronic thromboembolic disease
- PH due to schistosomiasis
- Active cancer
- Sickle cell anemia
- Prisoners and pregnant women will not be approached for the study
See the full eligibility criteria
- Outpatients of either gender, Age 18-75
- Diagnosis of precapillary PH (right heart catheterization demonstrating hemodynamic criteria of a mean pulmonary artery pressure (mPAP) ≥ 20 mmHg, pulmonary vascular resistance ≥ 5 WU, pulmonary capillary wedge pressure...
- Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
- On a stable dose of background PAH therapy for \> 90 days prior to study enrollment
- Women of childbearing potential must have a negative urine pregnancy test before MRI
- Moderate to severe heart disease (LVEF \< 45%, Severe LV hypertrophy, Moderate to severe valvular disease)
- Chronic thromboembolic disease
- PH due to schistosomiasis
- Active cancer
- Sickle cell anemia
- 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 participant or interfere with the participant's ability to comply with the protocol requirements
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.