129 Xenon Imaging in Patients Treated With Sotatercept

Launched by BASTIAAN DRIEHUYS · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial, called the "129 Xenon Imaging in Patients Treated with Sotatercept," is looking to see how well a special imaging technique called 129Xe MRI/MRS can help doctors monitor changes in the lungs of patients with pulmonary arterial hypertension (PAH) who are being treated with a medication called sotatercept. The goal is to find out if this non-invasive method can show improvements in the blood vessels of the lungs, which is an important part of managing PAH.

To participate in this trial, you must be between 18 and 75 years old and have a confirmed diagnosis of precapillary pulmonary hypertension, meaning there are specific measurements from heart tests that show you have this condition. You also need to have been on a stable treatment for your PAH for at least 90 days before joining the study. Participants will undergo MRI scans and will need to provide consent before any study activities begin. It’s important to note that individuals with certain heart diseases, active cancer, or conditions that might prevent them from safely undergoing an MRI will not be eligible. This study is not yet recruiting, so interested individuals will need to wait until the trial opens for enrollment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Outpatients of either gender, Age 18-75
• • 2. 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 ≤ 15 mmHg) in the setting of Group 1 (PAH)
• • 3. Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
• • 4. On a stable dose of background PAH therapy for \> 90 days prior to study enrollment
• • 5. Women of childbearing potential must have a negative urine pregnancy test before MRI
• Exclusion Criteria:
• • 1. Moderate to severe heart disease (LVEF \< 45%, Severe LV hypertrophy, Moderate to severe valvular disease)
• • 2. Chronic thromboembolic disease
• • 3. PH due to schistosomiasis
• • 4. Active cancer
• • 5. Sickle cell anemia
• • 6. Prisoners and pregnant women will not be approached for the study
• • 7. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
• • 8. 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