Reverse Remodeling of the Pulmonary Vasculature: a Longitudinal, Investigational Study of the Effects of Sotatercept.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the reverse remodeling of previously affected vascular structures by using intravascular ultrasound at Baseline, 3 month, 6 month or 9 month.
研究概览
简要总结
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:
- 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.
- Improvement in previously poorly or non-perfused areas rather than increased perfusion to previously perfused areas.
- No changes in baseline ventilation and improvement and ventilation/perfusion matching.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
To assess the reverse remodeling of previously affected vascular structures by using intravascular ultrasound at Baseline, 3 month, 6 month or 9 month.
时间窗: 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.
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.
To assess the reverse remodeling of previously affected vascular structures by using pulmonary wedge angiography at Baseline, 3 month, 6 month or 9 month.
时间窗: 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.
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.
To examine the longitudinal effects of sotatercept on ventilation perfusion matching with Ventilation/perfusion single photon emission computed tomography (V/Q SPECT)
时间窗: 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.
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.
次要结局
未报告次要终点
研究者
Franz Rischard, DO
DO
University of Arizona