Sacubitril/Valsartan Initiated in Hospitalized Patients with Heart Failure with Reduced Ejection Fraction after Hemodynamic Stabilization: Primary Results of the TRANSITION Study

• Published in: Journal of cardiac failure 2018-08, Vol.24 (8), p.S15-S15
• Main Authors: Wachter, Rolf, Senni, Michele, Belohlavek, Jan, Butylin, Dmytro, Noe, Adele, Pascual-Figal, Domingo
• Format: Article
• Language: English
• ISSN: 1071-9164; 1532-8414
• DOI: 10.1016/j.cardfail.2018.07.045

Sacubitril/valsartan (S/V) is indicated for the treatment of chronic heart failure with reduced ejection fraction (HFrEF). The TRANSITION study aims to provide evidence of safety and tolerability of S/V initiated early after decompensation requiring hospitalization in HFrEF patients. TRANSITION (NCT02661217) is a randomized, open-label study comparing S/V initiation pre- vs. post-discharge, after hemodynamic stabilization, in HFrEF patients admitted for acute decompensated HF, including patients with newly diagnosed HF. 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 completed acute HF treatment, were 24 hours free from intravenous diuretics, and then were randomized 1:1 within each stratum for initiation of S/V treatment either pre-discharge or during days 1-14 post-discharge. The primary endpoint is the proportion of patients achieving 200 mg S/V twice daily at 10 weeks post-randomization. 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. TRANSITION randomized 1002 patients. At baseline, mean age was 67 years and 75% were male. Mean LVEF was 29%, and 64% of patients were in NYHA Class II and 34% in NYHA Class III (Table). 287 patients (29%) had new-onset HFrEF and 243 (24%) were ACEI/ARB naïve. The last patient completed the 10 week visit in February 2018. Primary and secondary results data are expected in May and will be presented. TRANSITION recruited a HFrEF population similar to everyday clinical practice. This includes de novo as well worsening chronic HrEF and also patients naïve to ACEI/ARB therapy. The TRANSITION results will allow conclusions about safety and tolerability of early initiation of S/V during or following hospitalization for decompensated HFrEF.