Reverse Remodeling of the Pulmonary Vasculature: a Longitudinal, Investigational Study of the Effects of Sotatercept.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- To assess the reverse remodeling of previously affected vascular structures by using intravascular ultrasound at Baseline, 3 month, 6 month or 9 month. [Time frame: 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.]
- To assess the reverse remodeling of previously affected vascular structures by using pulmonary wedge angiography at Baseline, 3 month, 6 month or 9 month. [Time frame: 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.]
- To examine the longitudinal effects of sotatercept on ventilation perfusion matching with Ventilation/perfusion single photon emission computed tomography (V/Q SPECT) [Time frame: 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.]
Eligibility criteria
Inclusion Criteria - Feasibility Group:
- 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
Inclusion Criteria - "Real-world" treatment naïve cohort:
- Group 1 Pulmonary Hypertension (G1PH)-all types
- Must be treatment naïve
- Must be 18 years of age or older
Inclusion Criteria - "Real-world" prevalent cohort:
- Group 1 Pulmonary Hypertension (G1PH)-all types
- Must be 18 years of age or older
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- The Clinical and Translational Sciences Research Center — Tucson
Identifiers
NCT: NCT07487441 · 00006475