129 Xenon Imaging in Patients Treated With Sotatercept

NCT06351345 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Pro00115215
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pulmonary Hypertension; Pulmonary Arterial Hypertension

Keywords

Xenon; MRI

Outcome Measures

Primary Outcomes (2)

• Change in Xenon MRI Red Blood Cell (RBC) percentage

  baseline, 3,and 12 months

• Change in cardiogenic oscillation amplitudes

  baseline, 3, and 12 months

Study Arms (1)

Pulmonary Arterial Hypertension Patients Receving Sotatercept

OTHER

PAH patients receiving sotatercept as treatment for their PAH

Drug: 129Xe Hyperpolarized

Interventions

129Xe Hyperpolarized DRUG

Each xenon dose will be limited to a volume less than 25% of participant lung capacity (TLC).

Pulmonary Arterial Hypertension Patients Receving Sotatercept

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Moderate to severe heart disease (LVEF \< 45%, Severe LV hypertrophy, Moderate to severe valvular disease)
• Chronic thromboembolic disease
• PH due to schistosomiasis
• Active cancer
• Sickle cell anemia
• Prisoners and pregnant women will not be approached for the study
• Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
• Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the participant or interfere with the participant's ability to comply with the protocol requirements

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: collaborator
• Bastiaan Driehuys: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

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

Study Officials

• Sudarshan Rajagopal, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Salazar

CONTACT

+1 919 660 2026; claudia.salazar@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: October 27, 2025
• Primary Completion (Estimated): February 4, 2029
• Study Completion (Estimated): February 4, 2030
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)