A new prospective, multicenter, open-label clinical trial will evaluate early and rapid treprostinil afterload-lowering therapy as a potential disease-modifying treatment option for pulmonary arterial hypertension (PAH).
The new trial, known as ARTISAN (afterload reduction to improve right ventricular structure and function), will enroll approximately 50 subjects with confirmed PAH who are PAH treatment naive or received endothelin receptor antagonist and/or phosphodiesterase type 5 inhibitor therapy less than 6 months.
Participants will receive parenteral treprostinil intravenously or subcutaneously with rapid dose titration based on mean pulmonary artery pressure (mPAP) assessment. Participants may then transition to oral treprostinil while continuing to dose up titration for further reduction of mPAP. Treprostinil therapy, either parenteral or oral, may continue as tolerated for the goal of further reduction of mPAP until month 36.
The primary endpoint of ARTISAN is a change in right ventricular ejection fraction from baseline to month 12, as measured by cardiac magnetic resonance imaging. Key secondary endpoints include a change from baseline in mPAP, the ratio of stroke volume to end systolic volume, the ratio of tricuspid annular plane systolic excursion to pulmonary artery systolic pressure, and the Registry to Evaluate Early and Long-term PAH disease management (REVEAL) Lite 2 risk score, clinical improvement, and survival through month 36.
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To enroll, the study participants must have an mPAP greater than 35 mm Hg, World Health Organization functional class II or III, and REVEAL Lite 2 risk score of 9 or lower.
ARTISAN was presented in a poster session at the 43rd ISHLT Annual Meeting & Scientific Sessions.
Benza R, Lang I, Matsubara H, et al. 851. ARTISAN: a novel study of mean pulmonary artery pressure-targeted approach with early and rapid treprostinil therapy to reverse right ventricular remodeling in pulmonary arterial hypertension. Poster presented at the 43rd ISHLT Annual Meeting & Scientific Sessions; April 19-22, 2023; Denver, CO.
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). ClinicalTrials.gov. January 24, 2022. Updated April 28, 2023. Accessed May 3, 2023.