129 Xenon Imaging in Patients Treated With Sotatercept

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBastiaan Driehuys

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Moderate to severe heart disease (LVEF < 45%, Severe LV hypertrophy, Moderate to severe valvular disease)

Chronic thromboembolic disease

PH due to schistosomiasis

Active cancer

Trial design

Treatments tested in this trial

  • 129Xe Hyperpolarized

Treatment groups

14 Participants
are divided into 1 treatment group

Sponsors and collaborators

Bastiaan Driehuys

Lead sponsor

Duke University

Sponsor institution

Merck Sharp & Dohme LLC

Collaborator