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

March 17, 2026 updated by: Franz Rischard, DO

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: The clinical and translational sciences research center
  • Phone Number: (520) 626-8000
  • Email: esmeralda97h@arizona.edu

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • The Clinical and Translational Sciences Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Non-healthy adults with Group 1 Pulmonary Hypertension

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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.
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.
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.
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.

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)
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Franz Rischard, DO

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Franz Rischard, MD, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00006475

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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