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NCT Number: NCT05203510

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Banner University Medical Center (University of Arizona), Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parenteral Treprostinil

Drug

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

Other names: Remodulin

Oral Treprostinil

Drug

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

Other names: Orenitram

Primary outcomes

  1. 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

Secondary outcomes

  1. Change From Baseline in mPAP at Month 12

    Time frame: Baseline, Month 12

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

    Time frame: Baseline to Months 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).

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

    Time frame: Baseline, Month 12

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

    Time frame: Baseline, Month 12

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

    Time frame: Baseline, Month 12

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

    Time frame: 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

    Time frame: Baseline, Months 12, 24, and 36

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

    Time frame: Baseline, Months 12, 24, and 36

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

    Time frame: Baseline, Months 12, 24, and 36

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

    Time frame: 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

    Time frame: Baseline, Months 12, 24, and 36

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

    Time frame: Baseline to Months 12, 24, and 36

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

    Time frame: Baseline, Months 24 and 36

Sponsors and collaborators

Lead sponsor

United Therapeutics

Industry

Collaborators

  • Lung Biotechnology PBC

Registry information

Official study 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)

Acronym: ARTISAN

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Jan 24, 2022
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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