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New hope for PAH: rapid drug therapy aims to reverse heart damage

NCT ID NCT05203510

Disease control Sponsor: United Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether quickly starting and increasing a medication called treprostinil can lower blood pressure in the lungs and improve the heart's pumping ability in people with pulmonary arterial hypertension (PAH). The trial involves 52 adults with PAH and will measure changes in heart function over 12 months using MRI scans. The goal is to see if this approach can reverse damage to the right side of the heart.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

52 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension

Contacts and locations

Locations

  • Banner University Medical Center (University of Arizona)

    Phoenix, Arizona, 85006, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Carilion Clinic

    Roanoke, Virginia, 24014, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Community Health Network

    Indianapolis, Indiana, 46219, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Georgia Clinical Research

    Austell, Georgia, 30106, United States

  • Hartford Hospital

    Hartford, Connecticut, 06106, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • HonorHealth John C. Lincoln Medical Center

    Phoenix, Arizona, 85020, United States

  • Indiana University Health North Hospital

    Indianapolis, Indiana, 46202, United States

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104, United States

  • Prisma Health

    Greenville, South Carolina, 29605, United States

  • Temple Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • USF

    Tampa, Florida, 33606, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of California San Francisco - Fresno

    Fresno, California, 93701, United States

  • University of California San Francisco Pulmonary, Critical Care, Allergy and Sleep Medicine

    San Francisco, California, 94143, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Rochester Medical Center

    Rochester, New York, 14623, United States

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