The purpose of the Phase 2a study is to: 1) demonstrate that the estimated VentaProst dose is safe and equivalent in effect to a dose administered via epoprostenol aerosolization by the current off-label-use practice; and 2) demonstrate that an optimum effect can be rapidly obtained with VentaProst titration.
Part I: This part of the study is designed to demonstrate the dose equivalence between off-label aerosolized epoprostenol and VentaProst using a patient's hemodynamic parameters. Part II: This part of the study is designed to establish a dose response relationship of VentaProst to hemodynamic effect by dose escalation in patients who have had cardiac surgery with CPB.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
epoprostenol for inhalation via custom drug delivery system
Stanford University Medical Center
Stanford, California, United States
Rush University Medical Center
Chicago, Illinois, United States
Tufts Medical Center
Boston, Massachusetts, United States
Identify Equivalent Dose of VentaProst Necessary to Achieve a PD Response Comparable to Standard of Care Treatment (Part I)
The primary goal was to establish the dose of VentaProst necessary to achieve a PD response comparable to the standard of care. The first dose of VentaProst tested, 17 ng/kg/min, achieved the dose equivalency.
Time frame: Pharmacodynamic changes will be measured during surgery (Day 1), post-surgery (Day 1), and from start of study treatment (Day 1) through study completion (up to 30 days)
Optimal Dose Determination With VP Dose Escalation (Part II)
Calculate vascular resistance indicators for CI and CO, and PAPi at each dose level. Identify the VP dose where mPAP, VR(CO), VR(CI), CVP are lowest, and CI/CO are highest. Compare in a narrative to the selected VP optimal dose by the Investigator by individual patient.
Time frame: Pharmacodynamic changes will be measured during surgery (Day 1), post-surgery (Day 1), and from start of study treatment (Day 1) through study completion (up to 30 days)
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