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急性心不全で入院中の患者におけるエンパグリフロジンの効果を検証する研究

基本情報

NCT ID
NCT04157751
ステータス
完了
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
530
治験依頼者名
Boehringer Ingelheim

概要

This is a study in adults who are in hospital for acute heart failure. The purpose of this study is to find out whether starting to take a medicine called empagliflozin soon after first being treated in hospital helps people with acute heart failure. Participants are in the study for about 3 months. At the beginning, participants are still in hospital. Later, they visit the hospital about 3 times and get 1 phone call. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. It is used to treat type 2 diabetes. During the study, the doctors check whether participants have additional heart failure events like needing to go to the hospital again because of heart failure. The participants answer questions about how their heart failure affects their life. We then compare the results between the empagliflozin and placebo groups. The doctors also regularly check the general health of the participants.

対象疾患

Heart Failure

介入

Empagliflozin(DRUG)
Placebo to Empagliflozin(DRUG)

実施施設 (9)

独立行政法人 地域医療機能推進機構 九州病院

Fukuoka, Kitakyushu, Japan

独立行政法人国立病院機構水戸医療センター

Ibaraki, Higashiibaraki-gun, Japan

かわぐち呼吸器内科クリニック

Saitama, Kawaguchi, Japan

社会医療法人社団十全会 心臓病センター榊原病院

Okayama, Okayama, Japan

信州大学医学部附属病院

Nagano, Matsumoto, Japan

Saitama Sekishikai Hospital

Saitama, Sayama, Japan

神奈川県立循環器呼吸器病センター

Kanagawa, Yokohama, Japan

学校法人日本大学 日本大学医学部附属板橋病院

Tokyo, Itabashi-ku, Japan

大阪大学医学部附属病院

Osaka, Suita, Japan