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 (ARTISAN)

  • STATUS
    Recruiting
  • End date
    Sep 12, 2024
  • participants needed
    50
  • sponsor
    United Therapeutics
Updated on 7 October 2022

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).

Details
Condition Pulmonary Arterial Hypertension
Treatment oral treprostinil, Parenteral Treprostinil
Clinical Study IdentifierNCT05203510
SponsorUnited Therapeutics
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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) ≥3 Wood units
Pulmonary artery wedge pressure (PAWP) ≤15 mmHg
Treatment naïve or on a stable dose of an endothelin receptor antagonist (ERA) and/or
phosphodiesterase type 5 inhibitor (PDE-5i) for ≥30 days, but <6 months prior
to the Baseline visit
REVEAL Lite 2 risk score ≤9
WHO FC II or III
MWD >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 subject safety (for example, active infection, chronic thromboembolic pulmonary hypertension, or acute/recent deep vein thrombosis or pulmonary embolism)
cMRI-related Exclusion Criteria
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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