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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
129Xe Hyperpolarized
DrugEach xenon dose will be limited to a volume less than 25% of participant lung capacity (TLC).
Treatment groups
14 Participants
are divided into 1 treatment groupGroup A: Pulmonary Arterial Hypertension Patients Receving SotaterceptOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in Xenon MRI Red Blood Cell (RBC) percentage
Time frame
baseline, 3,and 12 months2
Change in cardiogenic oscillation amplitudes
Time frame
baseline, 3, and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov