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| Name | Class |
|---|---|
| Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility Group | 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 | 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 | This cohort will consist of 10 participants with Group 1 Pulmonary Hypertension (all types) to be enrolled in the second phase of the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
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Inclusion Criteria - Feasibility Group:
Inclusion Criteria - "Real-world" treatment naïve cohort:
Inclusion Criteria - "Real-world" prevalent cohort:
Exclusion Criteria:
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Non-healthy adults with Group 1 Pulmonary Hypertension
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The clinical and translational sciences research center | Contact | (520) 626-8000 | esmeralda97h@arizona.edu | |
| Study Coordinator | Contact | (520) 626-4804 | esmeralda97h@arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Franz Rischard, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Clinical and Translational Sciences Research Center | Tucson | Arizona | 85724 | United States |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| D002318 |
| Cardiovascular Diseases |