Rationale and Design of the Efficacy and Safety of Esaxerenone in Hypertensive Patients With Left Ventricular Hypertrophy (ESES-LVH) Study - Protocol for a Multicenter, Open-Label, Exploratory Interventional Study

Daisuke Sueta; Eiichiro Yamamoto; Hiroki Usuku; Satoru Suzuki; Taishi Nakamura; Kunihiko Matsui; Takaaki Akasaka; Kazuhito Shiosakai; Kotaro Sugimoto; Kenichi Tsujita; ESES-LVH Study Investigators

doi:10.1253/circrep.CR-21-0122

Rationale and Design of the Efficacy and Safety of Esaxerenone in Hypertensive Patients With Left Ventricular Hypertrophy (ESES-LVH) Study - Protocol for a Multicenter, Open-Label, Exploratory Interventional Study

Circ Rep. 2022 Jan 20;4(2):99-104. doi: 10.1253/circrep.CR-21-0122. eCollection 2022 Feb 10.

Authors

Daisuke Sueta^{1

2}, Eiichiro Yamamoto^{1

2}, Hiroki Usuku^{1

2

3}, Satoru Suzuki^{1

2}, Taishi Nakamura^{1

2}, Kunihiko Matsui⁴, Takaaki Akasaka⁵, Kazuhito Shiosakai⁶, Kotaro Sugimoto⁵, Kenichi Tsujita^{1

2}; ESES-LVH Study Investigators

Affiliations

¹ Department of Cardiovascular Medicine, Graduate School of Medical Science, Kumamoto University Kumamoto Japan.
² Center for Metabolic Regulation of Healthy Aging, Graduate School of Medical Science, Kumamoto University Kumamoto Japan.
³ Molecular Laboratory, Graduate School of Medical Science, Kumamoto University Kumamoto Japan.
⁴ Community, Family, and General Medicine, Faculty of Life Sciences, Graduate School of Medical Science, Kumamoto University Kumamoto Japan.
⁵ Primary Medical Science Department, Daiichi Sankyo Co., Ltd. Tokyo Japan.
⁶ Data Intelligence Department, Daiichi Sankyo Co., Ltd. Tokyo Japan.

Abstract

Background: The complication of left ventricular (LV) hypertrophy (LVH) is associated with increased incidence of major cardiovascular events. Hypertension is an independent risk factor among several factors contributing to the development of LVH, and thus appropriate treatment of both hypertension and LVH reduces the risk of developing heart failure. Mineralocorticoid-receptor blockers (MRBs) have been reported to improve the prognosis of LVH, but use of currently available MRBs is limited by adverse events. Esaxerenone is a novel selective nonsteroidal MRB recently approved for treatment of hypertension. Although the renoprotective effect of esaxerenone has been demonstrated in both preclinical and clinical studies, little data is available in terms of its cardioprotective effects. Methods and Results: This multicenter, open-label, exploratory interventional study was designed to evaluate the safety and efficacy of esaxerenone in combination with renin-angiotensin system (RAS) inhibitors or calcium-channel blockers (CCBs). Eligible criteria are hypertensive patients with LVH, and target blood pressure (BP) not reached with an RAS inhibitor or a CCB. The primary endpoints are change from baseline in seated home BP (early morning systolic/diastolic BPs), and change and %change from baseline in the LV mass index at the end of treatment. Conclusions: This study will provide the first clinical evidence of the antihypertensive effect and safety of esaxerenone in hypertensive patients with LVH.

Keywords: Esaxerenone; Exploratory interventional study; Hypertension; Left ventricular hypertrophy; Mineralocorticoid-receptor blockers.