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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Franz Rischard, DO
Study ID
NCT07487441
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Pulmonary Arterial Hypertension (PAH)
  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 15, 2026
Status verified
Mar 2026
Primary completion
Mar 15, 2028
Completion
Jun 15, 2028

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Clinical and Translational Sciences Research CenterTucsonArizona85724
Esme Study Coordinator
[email protected]
(520) 626-4804

Find similar trials in Tucson, AZ

By research site
The Clinical and Translational Sciences Research Center· Tucson, AZ

Related Studies