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Randomized Controlled Trial
. 2022 Aug 9;80(6):584-594.
doi: 10.1016/j.jacc.2022.05.027.

Sustained-Release Ivabradine Hemisulfate in Patients With Systolic Heart Failure

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Free article
Randomized Controlled Trial

Sustained-Release Ivabradine Hemisulfate in Patients With Systolic Heart Failure

Feiming Ye et al. J Am Coll Cardiol. .
Free article

Abstract

Background: Ivabradine has potent actions in reducing heart rate and improving clinical outcomes of chronic heart failure with reduced ejection fraction (HFrEF). At present, only the short-acting formulation of ivabradine is available that needs to be administered twice daily.

Objectives: This study sought to evaluate the role of ivabradine hemisulfate sustained release (SR), a novel long-acting formulation of ivabradine dosed once daily, in stable patients with HFrEF.

Methods: Patients with stabilized HFrEF in New York Heart Association functional class II-IV were enrolled and randomized to receive placebo or ivabradine SR in addition to standard medications. The primary endpoint was the change of left ventricular (LV) end-systolic volume index from baseline to week 32.

Results: We randomly assigned 181 patients to placebo and 179 patients to ivabradine SR. After 32 weeks, a significant improvement of LV end-systolic volume index from baseline was observed in both arms with a greater effect in the ivabradine SR arm. Ivabradine SR therapy also exhibited superiority in improving LV end-diastolic volume index, LV ejection fraction, resting heart rate, the Kansas City Cardiomyopathy Questionnaire score, and hospital admission for heart failure worsening and cardiovascular disease in comparison to placebo. Overall adverse events showed no difference between the treatment arms. There were fewer occurrences of worsening heart failure in the ivabradine SR arm.

Conclusions: The present study demonstrates that ivabradine SR once daily in addition to optimum standard therapy improved heart function in patients with HFrEF. (Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets [FIRST]; NCT02188082).

Keywords: chronic heart failure; heart rate; ivabradine; systolic dysfunction.

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Conflict of interest statement

Funding Support and Author Disclosures This work was supported by Jiangsu Hengrui Pharmaceuticals, Lianyungang, China. Jiangsu Hengrui Pharmaceuticals provided the investigational medicinal products and an unrestricted grant. Drs Lou and Cui are full-time employees of Jiangsu Hengrui Pharmaceuticals. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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