日本における胸腔内インピーダンス測定による心不全患者の体液状態モニタリング(J-HomeCARE II)
基本情報
- NCT ID
- NCT01221649
- ステータス
- 完了
- 試験のフェーズ
- 第4相
- 試験タイプ
- 介入
- 目標被験者数
- 198
- 治験依頼者名
- Biotronik Japan, Inc.
概要
The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Home Monitoring technology. In future, this will allow for automatic early detection of imminent decompensation at a presymptomatic stage and immediate initialization of clinical meaningful therapeutic interventions preventing heart failure (HF) related hospitalizations. The aim of this investigation is to record long-term impedance trends in heart failure patients with and without heart failure related events (hospitalizations due to acute decompensation) in order to develop algorithms for device-based early detection and warning of HF deterioration accompanied by pulmonary congestion.
対象疾患
介入
依頼者(Sponsor)
実施施設 (4)
広島市医師会運営・安芸市民病院
Hiroshima, Hiroshima, Japan
東京女子医科大学病院
Tokyo, Tokyo, Japan
小倉記念病院
Kitakyushu, Fukuoka, Japan
函館赤十字病院
Ise, Mie-ken, Japan