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Pulmonary Arterial HypertensionPhase 4ARTISANNCT05203510

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

A Phase 4 study testing Parenteral Treprostinil and Oral Treprostinil in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 28 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Parenteral Treprostinil and Oral Treprostinil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
28 sitesUnited States
Study dates
20 Oct 2022to 30 Apr 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • Georgia Clinical Research

    Austell, Georgia, 30106

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of California San Francisco - Fresno

    Fresno, California, 93701

  • Prisma Health

    Greenville, South Carolina, 29605

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • Indiana University Health North Hospital

    Indianapolis, Indiana, 46202

  • Community Health Network

    Indianapolis, Indiana, 46219

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Temple Hospital

    Philadelphia, Pennsylvania, 19140

  • Banner University Medical Center (University of Arizona)

    Phoenix, Arizona, 85006

  • HonorHealth John C. Lincoln Medical Center

    Phoenix, Arizona, 85020

  • Carilion Clinic

    Roanoke, Virginia, 24014

  • University of Rochester Medical Center

    Rochester, New York, 14623

  • University of California Davis Medical Center

    Sacramento, California, 95817

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

    San Francisco, California, 94143

  • USF

    Tampa, Florida, 33606

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

Other trials in United States

About this study

Official title: A Phase 4, Prospective, Multicenter, Single-Arm Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Patients With Pulmonary Arterial Hypertension: ARTISAN (Afterload Reduction To Improve Right Ventricular Structure And FuNction)

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).

Being tested
Parenteral Treprostinil, Oral Treprostinil
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parenteral TreprostinilDrug

    Also called Remodulin

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

  • Oral TreprostinilDrug

    Also called Orenitram

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

Study groups in NCT05203510
Study groupRoleWhat they receive
TreprostinilExperimentalParticipants 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.
Receives: Drug: Parenteral Treprostinil; Drug: Oral Treprostinil

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline, Month 12

Secondary outcomes (13)

  1. Change From Baseline in mPAP at Month 12

    Measured: Baseline, Month 12

  2. Number of Participants With Clinical Improvement From Baseline to Month 12, 24, and 36

    Clinical improvement is defined as meeting all 3 criteria: - improvement in six-minute walk distance (6MWD) increase ≥10% or ≥30 meters; - improvement in World Health Organization (WHO) functional class (FC) or maintenance of WHO FC I/II; - improvement in N-terminal pro-brain natriuretic peptide (NT-proBNP) decrease ≥30% or <300 ng/liter (L).

    Measured: Baseline to Months 12, 24, and 36

  3. Change From Baseline in RV-Pulmonary Artery (PA) Coupling Estimated by the Ratio of Stroke Volume by End Systolic Volume at Month 12

    Measured: Baseline, Month 12

  4. Change From Baseline in RV End-Diastolic Volume Index at Month 12

    Measured: Baseline, Month 12

  5. Change From Baseline in RV Stroke Volume Index at Month 12

    Measured: Baseline, Month 12

  6. Change From Baseline in 6MWD at Month 12, 24, and 36

    Measured: Baseline, Months 12, 24, and 36

  7. Change From Baseline in Registry to EValuate EArly and Long-Term PAH Disease Management (REVEAL) Lite 2 Risk Score at Months 12, 24, and 36

    Measured: Baseline, Months 12, 24, and 36

  8. Change From Baseline in WHO FC at Months 12, 24, and 36

    Measured: Baseline, Months 12, 24, and 36

  9. Change From Baseline in NT-proBNP at Months 12, 24, and 36

    Measured: Baseline, Months 12, 24, and 36

  10. Change From Baseline in Borg Dyspnea Score at Months 12, 24, and 36

    Measured: Baseline, Months 12, 24, and 36

  11. Change From Baseline in RV-PA Coupling Estimated by the Ratio of Tricuspid Annular Plane Systolic Excursion by Pulmonary Artery Systolic Pressure (TAPSE/PASP) at Months 12, 24, and 36

    Measured: Baseline, Months 12, 24, and 36

  12. Survival Rate: Number of Participants who Survived at Months 12, 24, and 36

    Measured: Baseline to Months 12, 24, and 36

  13. Change From Baseline in mPAP at Months 24 and 36

    Measured: Baseline, Months 24 and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start20 Oct 2022
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05203510
Sponsor's protocol ID
REM-PH-418
Acronym
ARTISAN
Status last verified
May 2025
First submitted
10 Jan 2022
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Parenteral Treprostinil and Oral Treprostinil in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Right Ventricular Ejection Fraction (RVEF), as Measured by Cardiac Magnetic Resonance Imaging (cMRI) at Month 12 (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05203510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.

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