학술논문
Rationale and design of an investigator-initiated, multicenter, prospective, placebo-controlled, double-blind, randomized trial to evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in type 2 diabetes and chronic kidney disease (FIVE-STAR)
Document Type
article
Author
Atsushi Tanaka; Hirotaka Shibata; Takumi Imai; Hisako Yoshida; Motoaki Miyazono; Naohiko Takahashi; Daiju Fukuda; Yosuke Okada; Hiroki Teragawa; Satoru Suwa; Keisuke Kida; Masao Moroi; Isao Taguchi; Shigeru Toyoda; Michio Shimabukuro; Kengo Tanabe; Kenichi Tanaka; Masaomi Nangaku; Koichi Node; the FIVE-STAR trial investigators
Source
Cardiovascular Diabetology, Vol 22, Iss 1, Pp 1-11 (2023)
Subject
Language
English
ISSN
1475-2840
Abstract
Abstract Background The overactivation of mineralocorticoid receptor (MR) plays a key pathological role in the progression of cardiovascular and renal diseases by promoting pro-inflammatory and pro-fibrotic signaling. Recently, it has been found that finerenone, a novel nonsteroidal selective MR antagonist, can robustly improve cardiorenal outcomes in patients with type 2 diabetes (T2D) and a wide spectrum of chronic kidney disease (CKD). However, the mechanisms underlying the cardiorenal benefits of finerenone are poorly understood. Further, whether the clinical benefits are mediated by an improvement in vascular stiffness is not confirmed. Therefore, the current study aims to evaluate the effects of finerenone on vascular stiffness as assessed using cardio ankle vascular index (CAVI) and relevant cardiorenal biomarkers in patients with T2D and CKD. Methods The Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in Type 2 Diabetes and Chronic Kidney Disease (FIVE-STAR) is an ongoing, investigator-initiated, multicenter, prospective, placebo-controlled, double-blind, randomized clinical trial in Japan. Its target sample size is 100 subjects. Recruitment will be performed from September 2023 to July 2024. After obtaining informed consent, eligible participants with T2D and CKD (25 mL/min/1.73 m2 ≤ estimated glomerular filtration ratio [eGFR]