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

Running, not enrolling · Phase 4

Conditions studied: Pulmonary Arterial Hypertension

In brief

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).

Key facts

Study ID

NCT05203510

Run by

United Therapeutics

People needed

52

Starts

2022-10-20

Expected to finish

2028-04-30

Last updated by the study team

2025-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• PAH-related Exclusion Criteria:
• Prior or current use of epoprostenol, treprostinil, iloprost, beraprost, or selexipag
• Positive vasoreactivity test in idiopathic, heritable, or drug/toxin induced PAH
• Amphetamine use within the past 12 months
• WHO Groups 2, 3, 4, and 5
• Use of any other investigational drug, device, or therapy within 30 days of the Baseline visit
• Moderate or severe hepatic impairment (Child-Pugh Class B and C)
• Any other clinically significant illness or abnormal laboratory value(s) measured during screening that, in the opinion of the Investigator, might adversely affect interpretation of the study data or participant safety (for example, active infection, chronic thromboembolic pulmonary hypertension, or acute/recent deep vein thrombosis or pulmonary embolism)
• Chronic atrial fibrillation, multiple premature ventricular or atrial contractions of clinical significance, or any other condition that would interfere with proper cardiac gating during cMRI
• Permanent cardiac pacemaker or automatic internal cardioverter that would interfere with conduct of cMRI
• Metallic implant (for example, defibrillator, neurostimulator, hearing aid, permanent infusion device, implantable pump, or body plates/screws/bolts) that would interfere with conduct of cMRI
• CardioMEMS-related Exclusion Criteria, if applicable:
• Previously implanted with CardioMEMS pulmonary artery Sensor or unwilling/unable to permit collection and perform upload (transmission) of pulmonary artery pressure (PAP) readings
• Unable to take dual antiplatelet or anticoagulation therapy for 30 days after CardioMEMS PA Sensor implantation unless the participant has an indication for warfarin or direct oral anticoagulant
• NOTE: Other inclusion and exclusion criteria may apply.

Where it is running

• Community Health Network — Indianapolis, Indiana, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• 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
• Indiana University Health North Hospital — Indianapolis, Indiana, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• University of Rochester Medical Center — Rochester, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States
• Oklahoma Heart Institute — Tulsa, Oklahoma, United States
• Temple Hospital — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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