Abstract 252: PredischaRge Initiation of Ivabradine in the ManagEment of Heart Failure: Results of the PRIME-HF Trial

Abstract

Background: Prior studies suggest that the hospital setting provides an important opportunity to initiate guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF). Ivabradine is a specific inhibitor of the I f current in the sinoatrial node that is FDA-approved for use in chronic HFrEF. A randomized trial conducted outside the US demonstrated that heart rate reduction with ivabradine improved clinical outcomes for ambulatory patients with chronic, symptomatic HFrEF. The initiation of ivabradine specifically in patients following stabilization for acute HF has not been evaluated and there are limited trial data on the use of ivabradine in US patients. Methods: The PredischaRge Initiation of Ivabradine in the ManagEment of Heart Failure (PRIME-HF) trial was a randomized, open-label study of pre-discharge initiation of twice-daily ivabradine versus usual care (i.e., post-discharge initiation of ivabradine at discretion of routine physician) for 180 days. Eligible patients were those hospitalized for acute HF but stabilized and preparing for discharge, with left ventricular ejection fraction ≤35%, in sinus rhythm with resting heart rate ≥70 bpm and on optimal GDMT including maximally-tolerated doses of beta-blockers. Given an aim to understand real-world use and barriers to medication acquisition, study drug was not provided. The primary endpoint was the proportion of patients using ivabradine at 180 days. Additional endpoints included heart rate change, patient-reported outcomes, beta-blocker use, barriers to ivabradine acquisition and clinical outcomes. Results: A total of 104 patients were randomized at 23 US hospitals. The primary results of the PRIME-HF study and important secondary endpoints will be presented. Conclusion: PRIME-HF is a trial evaluating implementation of evidence in the hospital following stabilization from acute HF in patients with HFrEF receiving optimal GDMT. This study also provides important data on the use of ivabradine in patients from the US.