Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Fresno, California and other locations
Dates
study started
completion around
Principal Investigator
by Eyad AlmasriMarc Simon
Headshot of Eyad Almasri
Eyad Almasri
Headshot of Marc Simon
Marc Simon

Description

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).

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)

Keywords

Pulmonary Arterial Hypertension, Familial Primary Pulmonary Hypertension, Hypertension, Ventricular Remodeling, Treprostinil, Parenteral Treprostinil, Oral Treprostinil

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

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.

Locations

  • UCSF - Fresno accepting new patients
    Fresno California 93701 United States
  • UCSF Pulmonary, Critical Care, Allergy and Sleep Medicine accepting new patients
    San Francisco California 94143 United States

Lead Scientists at UCSF

  • Eyad Almasri
    Eyad Almasri, M.D., specializes in pulmonary disease. He is board certified in Internal Medicine, Pulmonary, Critical Care and Sleep Medicine. Dr. Almasri completed a fellowship in critical care medicine at the University of Pittsburgh and an additional fellowship in pulmonary medicine at Western Pennsylvania Hospital.
  • Marc Simon
    Dr. Simon is director of Pulmonary Vascular Disease and the Pulmonary Hypertension Comprehensive Care Center. He has expertise as a cardiologist specializing in pulmonary hypertension, advanced heart failure, and heart transplantation.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
United Therapeutics
ID
NCT05203510
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated