Adamson Philip B, Conti Jamie B, Smith Andrew L, Abraham William T, Aaron Mark F, Aranda Juan M, Baker James, Bourge Robert C, Warner-Stevenson Lynne, Sparks Brandon
The Heart Failure Institute at Oklahoma Heart Hospital, Oklahoma Foundation for Cardiovascular Research, Oklahoma City, Oklahoma USA.
Clin Cardiol. 2007 Nov;30(11):567-75. doi: 10.1002/clc.20250.
The use of implantable cardioverter defibrillators (ICDs) has been proven effective in the prevention of sudden cardiac death (SCD) and constitutes standard of care in appropriate populations. Combining a pressure sensing system with ICD therapy represents the first attempt to provide continuous hemodynamic monitoring using a device previously designed exclusively for SCD protection.
REDUCE is a prospective, multicenter, randomized, single-blind, parallel-controlled trial designed to assess the safety of the Chronicle ICD system (single chamber ICD with a hemodynamic monitoring system) and the effectiveness of a management strategy guided by intracardiac pressure information among ICD-indicated New York Heart Association (NYHA) Class II or III heart failure (HF) patients. Those successfully implanted with a Chronicle ICD will be randomized to the Chronicle group or Control group. All patients will receive optimal medical therapy, but the hemodynamic information from the device will be used to guide patient management only in the Chronicle group. Primary endpoints include freedom from system-related complications and relative risk reduction of one or more HF-related events (hospitalizations, and emergency department and urgent care visits requiring intravenous therapy for HF). Approximately 850 patients will be enrolled in at least 75 centers in the United States to accrue the 419 events needed to test the primary effectiveness endpoint. Enrollment began in April 2006, and is expected to end during 2009.
REDUCE will assess the safety of the Chronicle ICD system and the effectiveness of a patient management strategy based on remote access to continuous intracardiac pressures in reducing HF-related events.
植入式心脏复律除颤器（ICD）已被证明在预防心源性猝死（SCD）方面有效，并成为合适人群的标准治疗方法。将压力传感系统与ICD治疗相结合，是首次尝试使用一种先前专门设计用于预防SCD的设备来提供连续血流动力学监测。
REDUCE是一项前瞻性、多中心、随机、单盲、平行对照试验，旨在评估Chronicle ICD系统（带有血流动力学监测系统的单腔ICD）的安全性，以及在符合ICD植入指征的纽约心脏协会（NYHA）II级或III级心力衰竭（HF）患者中，基于心内压力信息的管理策略的有效性。成功植入Chronicle ICD的患者将被随机分为Chronicle组或对照组。所有患者都将接受最佳药物治疗，但只有Chronicle组会使用该设备的血流动力学信息来指导患者管理。主要终点包括无系统相关并发症，以及一项或多项HF相关事件（住院、急诊科就诊和需要静脉治疗HF的紧急护理就诊）的相对风险降低。大约850名患者将在美国至少75个中心入组，以积累测试主要有效性终点所需的419例事件。入组于2006年4月开始，预计在2009年结束。
REDUCE将评估Chronicle ICD系统的安全性，以及基于远程获取连续心内压力的患者管理策略在减少HF相关事件方面的有效性。
