P886Initiation of sacubitril/valsartan in hospitalized patients with heart failure with reduced ejection fraction after hemodynamic stabilization: primary results of the TRANSITION study

Background: Sacubitril/valsartan (S/V) is indicated for the treatment of chronic heart failure with reduced ejection fraction (HFrEF). Evidence of safety and tolerability of S/V initiated early after decompensation requiring hospitalisation in HFrEF patients is lacking. Methods: TRANSITION (NCT02661217) is a randomised, open-label study comparing S/V initiation pre- vs. during days 1–14 post-discharge in HFrEF patients, admitted for acute decompensated HF after hemodynamic stabilization, including patients with newly diagnosed HF. All patients were stratified by pre-admission treatment status: on an angiotensin converting enzyme inhibitor (ACEI), on an angiotensin receptor blocker (ARB), or ACEI/ARB-naive. Patients were randomised 1:1 within each stratum for initiation of S/V treatment either pre-discharge or post-discharge. The primary endpoint is the proportion of patients achieving 200 mg S/V twice daily at 10 weeks post-randomisation. Secondary objectives assess the proportion of patients who achieve and maintain (i) a S/V dose of 100 and/or 200 mg twice daily or (ii) any dose of S/V for at least 2 weeks up to Week 10, and also (iii) the proportion of patients who permanently discontinue S/V owing to adverse events during the 10 week treatment period.