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

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  1   2 , Eiichiro Yamamoto  1   2 , Hiroki Usuku  1   2   3 , Satoru Suzuki  1   2 , Taishi Nakamura  1   2 , Kunihiko Matsui  4 , Takaaki Akasaka  5 , Kazuhito Shiosakai  6 , Kotaro Sugimoto  5 , Kenichi Tsujita  1   2 ; ESES-LVH Study Investigators
Affiliations

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 et al. Circ Rep. .

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.

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Conflict of interest statement

K. Tsujita has received honoraria and grants from Daiichi Sankyo Co., Ltd. The remaining authors from Kumamoto University have nothing to disclose. T. Akasaka, K. Shiosakai and K. Sugimoto are employees of Daiichi Sankyo Co., Ltd. K. Tsujita is a member of Circulation Reports’ Editorial Team.

Figures

Figure.
Figure.
Study design. RAS inhibitor cohort (n=60): esaxerenone + RAS inhibitor; CCB cohort (n=60): esaxerenone + CCB. CCB, calcium-channel blocker; eGFR,estimated glemerular filtration rate; RAS, renin-angiotensin system.
See this image and copyright information in PMC

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