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
NCT ID: NCT05203510
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
52 participants
INTERVENTIONAL
2022-10-20
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treprostinil
Participants will receive parenteral treprostinil at initial dose of 1.25 nanograms/kilogram/minute (at minimum) either intravenously or subcutaneously. Based on mPAP assessments and after a minimum dose of parenteral treprostinil is reached, at Investigator's (PI's) discretion, participants may transition to oral treprostinil and continue dose uptitration for further reduction of mPAP. Based on Month 12 mPAP assessment, participants may transition from parenteral to oral treprostinil at PI's discretion after completion of Month 12 assessment and continue uptitration for further reduction of mPAP. If minimum dose of parenteral treprostinil is not reached at Month 6/12 at PI's discretion, uptitration of parenteral treprostinil or oral treprostinil transition may occur to maintain normal mPAP.
Treprostinil therapy (parenteral or oral) may continue as tolerated toward goal of further reduction of mPAP until Month 36.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Lung Biotechnology PBC
INDUSTRY
Responsible Party
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Locations
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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
Indiana University Health North Hospital
Indianapolis, Indiana, United States
Community Health Network
Indianapolis, Indiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, 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
Prisma Health
Greenville, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Carilion Clinic
Roanoke, Virginia, United States
Countries
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Other Identifiers
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REM-PH-418
Identifier Type: -
Identifier Source: org_study_id
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