First Results of Soprano: Macitentan in Patients (pts) with Pulmonary Hypertension (PH) Post-Left Ventricular Assist Device (LVAD) Implantation
نویسندگان
چکیده
PurposeTo assess the efficacy and safety of macitentan in pts with PH post-LVAD.MethodsSOPRANO (NCT02554903) was a double-blind, randomized, study 10 mg once-daily vs placebo. Pts were ≥18 years LVAD implanted within 90 days prior to randomization, had mean pulmonary arterial pressure (mPAP) ≥25 mmHg, artery wedge (PAWP) ≤18 mmHg vascular resistance (PVR) >3 Wood units (WU). The primary endpoint change PVR at week 12 therapy from baseline.ResultsFifty-seven randomized: (n=28) or placebo (n=29). Baseline pt demographics characteristics well balanced. (mean [SD]) 4.3 [0.9] WU (macitentan) [1.3] (placebo). At 12, decreased 58.5% 75.5% (placebo) baseline. Mean placebo-corrected reduction 26.1% (95% CI: 58.0, 94.3; p=0.0158). Predefined secondary endpoints, notably including changes PAWP, not significantly different (Table). Another relevant hemodynamic parameter, transpulmonary gradient, (p=0.0499). incidence treatment adverse events (TAEs) 21.4% 24.1% (placebo); no TAEs occurred >1 patient arm. AEs interest included edema, anemia hypotension: reported 7 (25.0%), 3 (10.7%), 4 (14.3%) on (mostly mild-moderate) 5 (17.2%), 2 (6.9%) 1 (3.6%) placebo, respectively. Two discontinued for treatment-related AEs.ConclusionIn first prospective, multicenter, randomized controlled trial vasodilators early post-LVAD population, reduced tolerated. impact exercise capacity RV failure warrants further study. To post-LVAD. SOPRANO Fifty-seven AEs. In
منابع مشابه
Improvement of Left Ventricular Assist Device (LVAD) in Artificial Heart Using Particle Swarm Optimization
In this approach, the Left ventricular assist pump for patients with left ventricular failure isused. The failure of the left ventricle is the most common heart disease during these days. Inthis article, a State feedback controller method is used to optimize the efficiency of a samplingpump current. Particle Swarm Algorithm, which is a set of rules to update the position andvelocity, is applied...
متن کاملStroke and Left Ventricular Assist Device (LVAD)
Treatment of ischemic stroke for a patient on left ventricular assist device (LVAD) by neurointerventional means is rare and many anesthesia providers are unfamiliar with both LVAD and neurointerventional protocols. Examples of this include: 1) filling for continuous-flow LVAD depend on preload and the flow is inversely related to afterload; as mean arterial pressure (MAP) increases above 80 to...
متن کاملimprovement of left ventricular assist device (lvad) in artificial heart using particle swarm optimization
in this approach, the left ventricular assist pump for patients with left ventricular failure isused. the failure of the left ventricle is the most common heart disease during these days. inthis article, a state feedback controller method is used to optimize the efficiency of a samplingpump current. particle swarm algorithm, which is a set of rules to update the position andvelocity, is applied...
متن کاملLeft ventricular assist device for end-stage heart failure: results of the first LVAD destination program in the Netherlands
Today, heart transplantation is the golden standard for the treatment of patients with end-stage heart failure. A median survival time of more than 11 years (and 13 years for those surviving the first year) after transplantation will be hard to equal let alone to beat [1]. As a result of donor organ shortage, transplantation can, unfortunately, only be offered to a few patients. Supported by co...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Journal of Heart and Lung Transplantation
سال: 2021
ISSN: ['1053-2498', '1557-3117']
DOI: https://doi.org/10.1016/j.healun.2021.01.1767