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

N/ANot Yet RecruitingNCT07487441

Franz Rischard, DO30 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pulmonary Arterial Hypertension (PAH)Pulmonary Hypertension

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To assess the reverse remodeling of previously affected vascular structures by using intravascular ultrasound at Baseline, 3 month, 6 month or 9 month.

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.

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.

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.

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)

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.

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.

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts