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Clinical Trials in the USA / NCT05203510
Active, not recruiting Phase 4

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

NCT05203510 · tracked via the Priya Life Science USA tracker
Sponsor
United Therapeutics
Phase
Phase 4
Started
2022-10-20
Last updated
2025-12-09

Condition(s) studied

Pulmonary Arterial Hypertension

Investigational drug(s) / intervention(s)

Parenteral TreprostinilOral Treprostinil

Parenteral Treprostinil: Parenteral treprostinil will be administered per schedule specified in the arm description.

Oral Treprostinil: Oral treprostinil will be administered per schedule specified in the arm description.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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) \>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 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 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.

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
Banner University Medical Center (University of Arizona) Phoenix Arizona
HonorHealth John C. Lincoln Medical Center Phoenix Arizona
University of California San Francisco - Fresno Fresno California
Cedars-Sinai Medical Center Los Angeles California
University of California Davis Medical Center Sacramento California
University of California San Francisco Pulmonary, Critical Care, Allergy and Sleep Medicine San Francisco California
Hartford Hospital Hartford Connecticut
USF Tampa Florida
Georgia Clinical Research Austell Georgia
Northwestern Memorial Hospital Chicago Illinois
Indiana University Health North Hospital Indianapolis Indiana
Community Health Network Indianapolis Indiana
Brigham and Women's Hospital Boston Massachusetts
Henry Ford Health System Detroit Michigan
University of Nebraska Medical Center Omaha Nebraska
Morristown Medical Center Morristown New Jersey
University of Rochester Medical Center Rochester New York
University of North Carolina at Chapel Hill Chapel Hill North Carolina
Duke University Medical Center Durham North Carolina
University of Cincinnati Cincinnati Ohio
The Ohio State University Wexner Medical Center Columbus Ohio
Integris Baptist Medical Center Oklahoma City Oklahoma
Oklahoma Heart Institute Tulsa Oklahoma
Temple Hospital Philadelphia Pennsylvania
Medical University of South Carolina Charleston South Carolina
Prisma Health Greenville South Carolina
UT Southwestern Medical Center Dallas Texas
Carilion Clinic Roanoke Virginia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05203510 on ClinicalTrials.gov ↗ ← All trials in the USA