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

Abstract

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 predischarge 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. Results: 1002 patients were included, and the last patient was randomised on December 7th, 2017. The last patient having the week 10 visit is planned for end of February 2018. Primary and secondary results will be presented at ESC 2018 for the first time. Conclusion: TRANSITION will allow conclusions about safety and tolerance of early initiation of S/V during or following hospitalization for decompensated HFrEF. This will include de novo as well as worsening chronic HrEF and patients naïve to ACEI/ARB therapy.