What this study is
The goal of this study is to learn more about how sotatercept works and if it helps the lung arteries become healthier. Sotatercept will be associated with the following:
1. Improvement in capillary blush, reduce the tapering and tortuosity of affected vessels on pulmonary wedge angiography and decreased wall thickness on intravascular ultrasound in previously affected areas. 2. Improvement in previously poorly or non-perfused areas rather than increased perfusion to previously perfused areas. 3. No changes in baseline ventilation and improvement and ventilation/perfusion matching.
Study details
- Sponsor
- Franz Rischard, DO
- Conditions
- Pulmonary Arterial Hypertension (PAH) · Pulmonary Hypertension
- Enrolling
- 30 people
- Starts
- 2026-03-15
- Est. completion
- 2028-06-15
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedFeasibility Group
You may qualify if
- Group 1 Pulmonary Hypertension (G1PH)-must be idiopathic, drug induced, or hereditary (D/H/I)
- Age < 65 years at time of diagnosis
- Must be 18 years of age or older
You can't join if
- Contraindication to right heart catheterization (per PI)
- Prior exposure to sotatercept
- Hemoglobin > 18 g/dL at screening
- Estimated GFR < 30 mL/min at screening
- Platelet count <30 at screening
- Positive pregnancy test
"Real-world" treatment naïve cohort
You may qualify if
- Group 1 Pulmonary Hypertension (G1PH)-all types
- Must be treatment naïve
- Must be 18 years of age or older
You can't join if
- Contraindication to right heart catheterization (per PI)
- Prior exposure to sotatercept
- Hemoglobin > 18 g/dL at screening
- Estimated GFR < 30 mL/min at screening
- Platelet count <30 at screening
- Positive pregnancy test
"Real-world" prevalent cohort
You may qualify if
- Group 1 Pulmonary Hypertension (G1PH)-all types
- Must be 18 years of age or older
You can't join if
- Contraindication to right heart catheterization (per PI)
- Prior exposure to sotatercept
- Hemoglobin > 18 g/dL at screening
- Estimated GFR < 30 mL/min at screening
- Platelet count <30 at screening
- Positive pregnancy test
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe Clinical and Translational Sciences Research Center
Tucson, Arizona, United States
- Esme Study Coordinator · Contact(520) 626-4804esmeralda97h@arizona.edu
Study team
Sponsor
Franz Rischard, DO
Study ID 00006475
Principal investigator
Franz Rischard, MD
University of Arizona
CONTACT
The clinical and translational sciences research center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.