Heart Failure Institute at Oklahoma Heart Hospital and the Oklahoma Foundation for Cardiovascular Research, Oklahoma City, Oklahoma 73120, USA.
J Card Fail. 2011 Jan;17(1):3-10. doi: 10.1016/j.cardfail.2010.08.002.
Decompensated heart failure (HF) is associated with unacceptable morbidity and mortality risks. Recent implantable technology advancements allow frequent filling pressure monitoring and provide insight into HF pathophysiology and a new tool for HF management.
The CHAMPION trial is a prospective, multicenter, randomized, single-blind clinical trial testing the hypothesis that HF management guided by frequently assessed pulmonary artery pressures is superior to traditional methods. A total of 550 subjects with New York Heart Association (NYHA) functional class III HF were enrolled at 64 sites in the United States. All subjects received the CardioMEMS HF sensor as a permanent pulmonary artery implant and were randomized to the treatment or the control group before discharge. The treatment group received traditional HF management guided by hemodynamic information from the sensor. The control group received traditional HF disease management. Safety endpoints include freedom from device/system-related complications and freedom from HF sensor failure at 6 months. The efficacy endpoint is a reduction in the rate of HF-related hospitalizations in the treatment group versus the control group at 6 months.
The CHAMPION trial will investigate the safety and clinical efficacy of the CardioMEMS hemodynamic monitoring system and may establish this management strategy as a new paradigm for the medical management of patients with symptomatic HF.
失代偿性心力衰竭（HF）与不可接受的发病率和死亡率风险相关。最近的植入式技术进步允许频繁监测充盈压，并深入了解 HF 病理生理学，为 HF 管理提供了一种新工具。
CHAMPION 试验是一项前瞻性、多中心、随机、单盲临床试验，旨在检验以下假设：通过频繁评估肺动脉压力来指导 HF 管理优于传统方法。在美国 64 个地点共招募了 550 名纽约心脏协会（NYHA）功能分级 III HF 患者。所有患者均接受 CardioMEMS HF 传感器作为永久性肺动脉植入物，并在出院前随机分为治疗组或对照组。治疗组接受基于传感器血流动力学信息的传统 HF 管理。对照组接受传统 HF 疾病管理。安全性终点包括 6 个月时无器械/系统相关并发症和 HF 传感器故障。疗效终点是治疗组与对照组 6 个月时 HF 相关住院率的降低。
CHAMPION 试验将研究 CardioMEMS 血流动力学监测系统的安全性和临床疗效，并可能将这种管理策略确立为治疗有症状 HF 患者的一种新范例。
