Saint Louis University School of Medicine, Saint Louis, MO, USA.
Am Heart J. 2012 Jun;163(6):954-962.e1. doi: 10.1016/j.ahj.2012.03.021.
Imbalance between the parasympathetic and sympathetic nervous systems is a recognized contributor to progression of chronic heart failure. Current therapy with beta adrenergic antagonists is designed to moderate the up-regulation of norepinephrine and sympathetic effects; however, to date, there are no therapies that specifically address the withdrawal of parasympathetic influences on cardiac function and structure.
METHODS/RESULTS: In order to evaluate the impact of vagus nerve stimulation, an international multi-center randomized clinical trial (INOVATE-HF) has been designed to assess safety and efficacy of vagus nerve stimulation in symptomatic patients with heart failure on optimal medical therapy using the CardioFit System (BioControl Medical, Yehud, Israel). Up to 650 patients from 80 sites will be recruited and randomized in a 3:2 ratio to receive active treatment or standard optimal medical therapy. Inclusion criteria include left ventricular systolic dysfunction, the presence of New York Heart Association Class III symptoms, sinus rhythm, and QRS width less than 120 milliseconds. The study is powered to detect differences in the primary efficacy end point of all-cause mortality and heart failure hospitalization and 2 safety end points.
Vagal nerve stimulation with CardioFit as a treatment for symptomatic heart failure is under active investigation as a novel approach to restore balance between the sympathetic and parasympathetic nervous systems. If shown to be safe and effective in decreasing heart failure events and mortality, this novel approach will impact the treatment paradigm for heart failure.
副交感神经系统和交感神经系统之间的失衡是慢性心力衰竭进展的公认原因。目前，β肾上腺素能拮抗剂的治疗旨在调节去甲肾上腺素和交感神经效应的上调；然而，迄今为止，还没有专门针对心脏功能和结构的副交感神经影响的撤退的治疗方法。
方法/结果：为了评估迷走神经刺激的影响，设计了一项国际多中心随机临床试验（INOVATE-HF），以评估使用 CardioFit 系统（BioControl Medical，Yehud，以色列）对最佳药物治疗的有症状心力衰竭患者进行迷走神经刺激的安全性和疗效。将从 80 个地点招募多达 650 名患者，并以 3:2 的比例随机接受主动治疗或标准最佳药物治疗。纳入标准包括左心室收缩功能障碍、存在纽约心脏协会 III 级症状、窦性节律和 QRS 宽度小于 120 毫秒。该研究的目的是检测全因死亡率和心力衰竭住院的主要疗效终点以及 2 个安全性终点的差异。
使用 CardioFit 的迷走神经刺激作为治疗有症状心力衰竭的方法正在积极研究中，作为恢复交感和副交感神经系统之间平衡的一种新方法。如果证明在减少心力衰竭事件和死亡率方面是安全有效的，这种新方法将影响心力衰竭的治疗模式。
