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129Xenon MR Imaging and Spectroscopy Response to Sotatercept in Pulmonary Arterial Hypertension

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Determine the ability of 129Xe MRI/MRS biomarker signatures to non-invasively monitor pulmonary vascular reverse remodeling induced by sotatercept in pulmonary arterial hypertension (PAH).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Outpatients of either gender, Age 18-75

• Diagnosis of precapillary PH (right heart catheterization demonstrating hemodynamic criteria of a mean pulmonary artery pressure (mPAP) ≥ 20 mmHg, pulmonary vascular resistance ≥ 5 WU, pulmonary capillary wedge pressure ≤ 15 mmHg) in the setting of Group 1 (PAH)

• Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).

• On a stable dose of background PAH therapy for \> 90 days prior to study enrollment

• Women of childbearing potential must have a negative urine pregnancy test before MRI

Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
Contact Information
Primary
Claudia Salazar
claudia.salazar@duke.edu
+1 919 660 2026
Time Frame
Start Date: 2025-10-27
Estimated Completion Date: 2030-02-04
Participants
Target number of participants: 14
Treatments
Other: Pulmonary Arterial Hypertension Patients Receving Sotatercept
PAH patients receiving sotatercept as treatment for their PAH
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Bastiaan Driehuys

This content was sourced from clinicaltrials.gov