Status:
ACTIVE_NOT_RECRUITING
A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension
Lead Sponsor:
United Therapeutics
Collaborating Sponsors:
Lung Biotechnology PBC
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 r...
Eligibility Criteria
Inclusion
- Confirmed PAH (WHO Group 1) classified by one of the following subgroups:
- Idiopathic, heritable or drug/toxin induced (with the exception of amphetamine-induced PAH)
- Associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥1 year)
- Associated with connective tissue disease
- Associated with human immunodeficiency virus infection
- Baseline visit right heart catheterization (RHC) must also meet the following criteria:
- mPAP \>35 mmHg
- Pulmonary vascular resistance (PVR) \>2 Wood units
- Pulmonary artery wedge pressure (PAWP) ≤15 mmHg
- On a stable dose of an endothelin receptor antagonist (ERA) and/or phosphodiesterase type 5 inhibitor (PDE-5i) or soluble guanylate cyclase stimulator (sGC) therapy or if treatment naïve, willing to take one of these medications in addition to study drug
- REVEAL Lite 2 risk score ≤9
- WHO FC II or III
- 6MWD \>165 meters
Exclusion
- PAH-related
Key Trial Info
Start Date :
October 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2028
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05203510
Start Date
October 20 2022
End Date
April 30 2028
Last Update
December 9 2025
Active Locations (28)
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1
Banner University Medical Center (University of Arizona)
Phoenix, Arizona, United States, 85006
2
HonorHealth John C. Lincoln Medical Center
Phoenix, Arizona, United States, 85020
3
University of California San Francisco - Fresno
Fresno, California, United States, 93701
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048