Rationale and Design of the Double-Blind, Randomized, Placebo-Controlled Multicenter Trial on Efficacy of Early Initiation of Eplerenone Treatment in Patients with Acute Heart Failure (EARLIER)

Masanori Asakura, Haruko Yamamoto, Kuniya Asai, Akihisa Hanatani, Ken ichi Hirata, Atsushi Hirayakma, Kazuo Kimura, Youichi Kobayashi, Shin ichi Momomura, Yoshihisa Nakagawa, Yutaro Nishi, Yoshihiko Saito, Yasuhiro Satoh, Takahisa Yamada, Akira Yamashina, Satoshi Yasuda, Tsutomu Yoshikawa, Akiko Kada, Hiroyuki Uesaka, Masafumi Kitakaze

研究成果: Article査読

7 被引用数 (Scopus)

抄録

Methods: EARLIER is an event-driven clinical trial with an estimated enrolment of 300 patients hospitalized with ADHF with reduced left ventricular ejection fraction. ADHF includes ischemic or non-ischemic HF, and patients can be enrolled within 72 h after the visit to the hospital. We randomize the patients taking standard therapies for ADHF to the eplerenone and placebo groups. Eplerenone, either 25 or 50 mg, is administered for 6 months in the eplerenone group, and the corresponding placebo is administered in the placebo group on top of the standard care. We set the primary endpoint as the incidence of the composite endpoint (cardiac death or first re-hospitalization due to cardiac disease) 6 months after the enrollment, and also check the quality of life, i.e., exercise capacity and safety features of eplerenone.

Background and Aims: Aldosterone is one of the major factors to cause organ damage during an acute phase of heart failure (HF), and many reports have demonstrated that patients with acute decompensated HF (ADHF) have high blood aldosterone concentrations, and the high aldosterone concentrations predict poor prognosis in patients with HF. These findings suggest that eplerenone, an antagonist of aldosterone receptors may provide a new concept and strategy for the treatment of ADHF, protecting the heart and other organs during chronic phases, depending on the restoration of hemodynamic abnormalities.

Conclusion and Perspectives: EARLIER is a clinical trial of eplerenone targeting ADHF and also the first multicenter investigator-initiated phase III trial in the cardiovascular field in Japan, funded by the Japanese government.

本文言語English
ページ(範囲)179-185
ページ数7
ジャーナルCardiovascular Drugs and Therapy
29
2
DOI
出版ステータスPublished - 2015 4 1
外部発表はい

ASJC Scopus subject areas

  • 薬理学
  • 循環器および心血管医学
  • 薬理学(医学)

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「Rationale and Design of the Double-Blind, Randomized, Placebo-Controlled Multicenter Trial on Efficacy of Early Initiation of Eplerenone Treatment in Patients with Acute Heart Failure (EARLIER)」の研究トピックを掘り下げます。これらがまとまってユニークなフィンガープリントを構成します。

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