A study of a mean pulmonary artery pressure-targeted approach with early and rapid treprostinil therapy to reverse right ventricular remodeling in participants with PAH (ARTISAN)
ClinicalTrials.gov
NCT05203510
Status
Recruiting
Enrolment
Estimated 50 participants in 25 sites in United States
Objective
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).
Eligibility criteria
- Male or Female, 18 years and older
- Confirmed PAH classified by one of the following subgroups:
- Idiopathic, heritable, or drug/toxin 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 and/or phosphodiesterase type 5 inhibitor or soluble guanylate cyclase stimulator therapy for ≥30 days, but <6 months prior to the Baseline visit
- REVEAL Lite 2 risk score ≤9
- World Health Organization Functional Class II or III 6-minute walk distance >165 meters
- All other applicable inclusion and exclusion criteria are met
Treatment
Participants will receive parenteral treprostinil therapy either intravenously or subcutaneously with rapid dose titration based on wirelessly mPAP assessment, and after target dose and mPAP level is reached, participants may transition to oral treprostinil and continue up-titration in dose towards further reduction of mPAP until Month 12. Treprostinil therapy (parenteral or oral) may continue towards the goal of further reduction of mPAP until Month 36.
Primary endpoint
The primary endpoint is the change from Baseline in right ventricular ejection fraction (RVEF), as measured by cardiac magnetic resonance imaging at Month 12. ARTISAN is sponsored by United Therapeutics Corporation, conducted by Lung Biotechnology, in collaboration with Abbott. For contact information or a list of locations where the trial will be run, please click the link below.