Reverse Remodeling of the Pulmonary Vasculature: a Longitudinal, Investigational Study of the Effects of Sotatercept.

Franz Rischard, DO

Status: Not yet enrolling

Conditions: Pulmonary Arterial Hypertension (PAH); Pulmonary Hypertension

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07487441

00006475

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

30 participants in 3 patient groups

Feasibility Group

Description:

The feasibility group will consist of 10 participants with Group 1 Pulmonary Hypertension (idiopathic, drug induced, or hereditary) to be enrolled in the first phase of the study.

Real World Cohort - Treatment Naïve Cohort

Description:

This cohort will consist of 10 participants with Group 1 Pulmonary Hypertension (all types), treatment naïve, to be enrolled in the second phase of the study.

Real World Cohort - Prevalent Cohort

Description:

This cohort will consist of 10 participants with Group 1 Pulmonary Hypertension (all types) to be enrolled in the second phase of the study.