BACKGROUND: 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. METHODS: 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. CONCLUSIONS: 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.
RCT Entities:
BACKGROUND: 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. METHODS: 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. CONCLUSIONS: 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.
Authors: Ya-Li Zheng; Xiao-Rong Ding; Carmen Chung Yan Poon; Benny Ping Lai Lo; Heye Zhang; Xiao-Lin Zhou; Guang-Zhong Yang; Ni Zhao; Yuan-Ting Zhang Journal: IEEE Trans Biomed Eng Date: 2014-05 Impact factor: 4.538
Authors: Dariusz Dudek; Waldemar Banasiak; Wojciech Braksator; Jacek Dubiel; Tomasz Grodzicki; Piotr Hoffman; Mariusz Kuśmierczyk; Grzegorz Opolski; Piotr Ponikowski; Jacek Różański; Jerzy Sadowski; Wojciech Wojakowski; Marcin Grabowski; Katarzyna Bondaryk; Jacek Walczak; Izabela Pieniążek; Maciej Grys; Anna Lesiak-Bednarek; Piotr Przygodzki Journal: Cardiol J Date: 2019-02-14 Impact factor: 2.737