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

NCT07487441 | Not Yet Recruiting DMC

• 1 other identifier: 00006475
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Improvement in previously poorly or non-perfused areas rather than increased perfusion to previously perfused areas.
3. 3.No changes in baseline ventilation and improvement and ventilation/perfusion matching.

Conditions

Pulmonary Arterial Hypertension (PAH); Pulmonary Hypertension

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-healthy adults with Group 1 Pulmonary Hypertension

You may qualify if:

• 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
• Group 1 Pulmonary Hypertension (G1PH)-all types
• Must be treatment naïve
• Must be 18 years of age or older
• Group 1 Pulmonary Hypertension (G1PH)-all types
• Must be 18 years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Franz Rischard, DO: lead
• Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA: collaborator

Study Sites (1)

The Clinical and Translational Sciences Research Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Franz Rischard, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The clinical and translational sciences research center

CONTACT

(520) 626-8000; esmeralda97h@arizona.edu

Study Coordinator

CONTACT

(520) 626-4804; esmeralda97h@arizona.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DO

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 23, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)