Active — Not RecruitingPhase 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

United States52 participantsStarted 2022-10-20

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, i…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Right Ventricular Ejection Fraction (RVEF), as Measured by Cardiac Magnetic Resonance Imaging (cMRI) at Month 12

Timeframe: Baseline, Month 12

Trial details

NCT IDNCT05203510

SponsorUnited Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-30

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.