The primary objective of this study is to assess the effect of early and rapid treprostinil therapy for mean pulmonary artery pressure (mPAP) reduction to improve right ventricular (RV) function and reverse RV remodeling in participants with pulmonary arterial hypertension (PAH).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Parenteral treprostinil will be administered per schedule specified in the arm description.
Oral treprostinil will be administered per schedule specified in the arm description.
Change From Baseline in Right Ventricular Ejection Fraction (RVEF), as Measured by Cardiac Magnetic Resonance Imaging (cMRI) at Month 12
Time frame: Baseline, Month 12
Change From Baseline in mPAP at Month 12
Time frame: Baseline, Month 12
Number of Participants With Clinical Improvement From Baseline to Month 12, 24, and 36
Clinical improvement is defined as meeting all 3 criteria: - improvement in six-minute walk distance (6MWD) increase ≥10% or ≥30 meters; - improvement in World Health Organization (WHO) functional class (FC) or maintenance of WHO FC I/II; - improvement in N-terminal pro-brain natriuretic peptide (NT-proBNP) decrease ≥30% or \<300 ng/liter (L).
Time frame: Baseline to Months 12, 24, and 36
Change From Baseline in RV-Pulmonary Artery (PA) Coupling Estimated by the Ratio of Stroke Volume by End Systolic Volume at Month 12
Time frame: Baseline, Month 12
Change From Baseline in RV End-Diastolic Volume Index at Month 12
Time frame: Baseline, Month 12
Change From Baseline in RV Stroke Volume Index at Month 12
Time frame: Baseline, Month 12
Change From Baseline in 6MWD at Month 12, 24, and 36
Time frame: Baseline, Months 12, 24, and 36
Change From Baseline in Registry to EValuate EArly and Long-Term PAH Disease Management (REVEAL) Lite 2 Risk Score at Months 12, 24, and 36
Time frame: Baseline, Months 12, 24, and 36
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Banner University Medical Center (University of Arizona)
Phoenix, Arizona, United States
HonorHealth John C. Lincoln Medical Center
Phoenix, Arizona, United States
University of California San Francisco - Fresno
Fresno, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California San Francisco Pulmonary, Critical Care, Allergy and Sleep Medicine
San Francisco, California, United States
Hartford Hospital
Hartford, Connecticut, United States
USF
Tampa, Florida, United States
Georgia Clinical Research
Austell, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
...and 18 more locations
Change From Baseline in WHO FC at Months 12, 24, and 36
Time frame: Baseline, Months 12, 24, and 36
Change From Baseline in NT-proBNP at Months 12, 24, and 36
Time frame: Baseline, Months 12, 24, and 36
Change From Baseline in Borg Dyspnea Score at Months 12, 24, and 36
Time frame: Baseline, Months 12, 24, and 36
Change From Baseline in RV-PA Coupling Estimated by the Ratio of Tricuspid Annular Plane Systolic Excursion by Pulmonary Artery Systolic Pressure (TAPSE/PASP) at Months 12, 24, and 36
Time frame: Baseline, Months 12, 24, and 36
Survival Rate: Number of Participants who Survived at Months 12, 24, and 36
Time frame: Baseline to Months 12, 24, and 36
Change From Baseline in mPAP at Months 24 and 36
Time frame: Baseline, Months 24 and 36