Reverse Remodeling of the Pulmonary Vasculature: a Longitudinal, Investigational Study of the Effects of Sotatercept.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorFranz Rischard, DO
About this trial
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.
Eligibility criteria
Qualifiers
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
Group 1 Pulmonary Hypertension (G1PH)-all types
Disqualifiers
Contraindication to right heart catheterization (per PI)
Prior exposure to sotatercept
Hemoglobin > 18 g/dL at screening
Estimated GFR < 30 mL/min at screening
Trial design
Treatments tested in this trial
- Not listed
Trial groups
30 Participants
are grouped into 3 trial groupsSponsors and collaborators
Franz Rischard, DO
Lead sponsor
University of Arizona
Sponsor institution
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Collaborator
Source ClinicalTrials.gov