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document
Rationale and study design of the increase of vagal tone in heart failure study : INOVATE-HF . BACKGROUND 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 . CONCLUSION 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 .
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Intervention_Physical
CardioFit System
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Intervention_Physical
standard optimal medical therapy .
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Intervention_Physical
CardioFit
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Outcome_Other
safety and efficacy
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Outcome_Mortality
all-cause mortality
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Outcome_Physical
heart failure hospitalization
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Outcome_Physical
heart failure events
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Outcome_Mortality
mortality