Observational Study of Sotatercept for Pulmonary Arterial Hypertension
This observational study aims to understand how sotatercept affects the lung arteries in people with Pulmonary Arterial Hypertension (PAH), a condition where blood vessels in the lungs become narrow. Researchers want to see if sotatercept can help reverse damage to these vessels, making them healthier. They will use special imaging techniques like intravascular ultrasound and pulmonary wedge angiography to look for improvements in the blood vessels. They will also check how well air and blood flow through the lungs using a V/Q SPECT scan. The study is looking for adults aged 18 to 65 with PAH. The goal is to see if sotatercept leads to healthier lung arteries and better blood flow.
- Study design
- This is an observational study with a planned enrollment of 30 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will undergo intravascular ultrasound, pulmonary wedge angiography, and V/Q SPECT scans at different time points, including at the beginning of the study, and at 3, 6, or 9 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 9 months, with evaluations at baseline, 3 months, 6 months, or 9 months depending on their group.
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Reverse Remodeling of the Pulmonary Vasculature: a Longitudinal, Investigational Study of the Effects of Sotatercept.
At a glance
Conditions
NCT07487441
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
The Clinical and Translational Sciences Research Center
Tucson, Arizonastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Franz Rischard, MD · PRINCIPAL_INVESTIGATOR · University of Arizona
Who to contact
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What this trial measures
- To assess the reverse remodeling of previously affected vascular structures by using intravascular ultrasound at Baseline, 3 month, 6 month or 9 month.At Baseline and 6 month Evaluation for phase 1 feasibility group and Phase 2 prevalent group. At Baseline, 3 month evaluation and 9 month Evaluation for phase 2 treatment-naive group.
This is a medical imaging technique to see inside blood the vessels, especially the arteries around the heart. A catheter with an ultrasound probe at the tip of it will be inserted into a blood vessel and guided to the area that needs to be examined and images of the inside of the vessel will be obtained.
- To assess the reverse remodeling of previously affected vascular structures by using pulmonary wedge angiography at Baseline, 3 month, 6 month or 9 month.At Baseline and 6 month Evaluation for phase 1 feasibility group and Phase 2 prevalent group. At Baseline, 3 month evaluation and 9 month Evaluation for phase 2 treatment-naive group.
The pulmonary wedge angiography will look at the blood vessels in the lungs to see how blood flows. A catheter is inserted into a vein and it is moved carefully until it reaches the pulmonary artery and temporarily blocks that small vessel. A contrast dye will be injected through the catheter making the blood vessels visible on x-ray images. Several images are captured with the dye (contrast), called an angiogram.
- To examine the longitudinal effects of sotatercept on ventilation perfusion matching with Ventilation/perfusion single photon emission computed tomography (V/Q SPECT)At Baseline and 6 month Evaluation for phase 1 feasibility group and Phase 2 prevalent group. At Baseline, 3 month evaluation and 9 month Evaluation for phase 2 treatment-naive group.
During the V/Q SPECT, participants will breathe in small amounts of radioactive tracers and will receive an injection of another tracer into your vein that flows with your blood into your lungs. The special camera takes pictures of the tracers to see where air and blood flow in your lungs.