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

• Status: Not yet recruiting
• Trial end date: 2026-05-31
• Target enrollment: 0
• Participant gender: All

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 reverse RV remodeling in participants with pulmonary arterial hypertension (PAH).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: United Therapeutics
• Collaborator: Lung Biotechnology PBC
• Treatments: Treprostinil

Criteria

Inclusion Criteria:

• 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) ≥3 Wood units

• Pulmonary artery wedge pressure (PAWP) ≤15 mmHg

• Treatment naïve or on a stable dose of an endothelin receptor antagonist (ERA) and/or phosphodiesterase type 5 inhibitor (PDE-5i) for ≥30 days, but <6 months prior to the Baseline visit

• REVEAL Lite 2 risk score ≤9

• WHO FC II or III

• 6MWD >165 meters

Exclusion Criteria:

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 subject safety (for example, active infection, chronic thromboembolic pulmonary hypertension, or acute/recent deep vein thrombosis or pulmonary embolism)

cMRI-related Exclusion Criteria:

• 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.