Aim The neural cardiac therapy for heart failure (NECTAR-HF)was a randomized sham-controlled trial designed to evaluate whether a single dose of vagal nerve stimulation (VNS) would attenuate cardiac remodelling, improve cardiac function and increase exercise capacity in symptomatic heart failure patients with severe left ventricular (LV) systolic dysfunction despite guideline recommended medical therapy. Methods Patientswererandomizedina 2 : 1ratiotoreceivetherapy (VNSON) orcontrol (VNSOFF) for a 6-monthperiod.Theprimary endpointwas the change in LVend systolic diameter (LVESD) at 6months for control vs. therapy, with secondary endpoints of other echocardiographymeasurements, exercise capacity, quality-of-life assessments, 24-hHolter, and circulating biomarkers. Results Of the 96 implanted patients, 87 had paired datasets for the primary endpoint. Change in LVESD from baseline to 6 months was-0.04 ± 0.25 cm in the therapy group compared with-0.08 ± 0.32 cm in the control group (P = 0.60). Additional echocardiographic parameters of LV end diastolic dimension, LV end systolic volume, left ventricular end diastolic volume, LV ejection fraction, peak V02, and N-terminal pro-hormone brain natriuretic peptide failed to show superiority compared to the control group. However, therewere statistically significant improvements in quality of life for the Minnesota Living with Heart Failure Questionnaire (P = 0.049), New York Heart Association class (P = 0.032), and the SF-36 Physical Component (P = 0.016) in the therapy group. Conclusion Vagal nerve stimulation as delivered in the NECTAR-HF trial failed to demonstrate a significant effect on primary and secondary endpoint measures of cardiac remodelling and functional capacity in symptomatic heart failure patients, but quality-of-life measures showed significant improvement

Chronic vagal stimulation for the treatment of low ejection fraction heart failure: Results of the NEural Cardiac TherApy for Heart Failure (NECTAR-HF) randomized controlled trial

DE FERRARI, GAETANO;
2015-01-01

Abstract

Aim The neural cardiac therapy for heart failure (NECTAR-HF)was a randomized sham-controlled trial designed to evaluate whether a single dose of vagal nerve stimulation (VNS) would attenuate cardiac remodelling, improve cardiac function and increase exercise capacity in symptomatic heart failure patients with severe left ventricular (LV) systolic dysfunction despite guideline recommended medical therapy. Methods Patientswererandomizedina 2 : 1ratiotoreceivetherapy (VNSON) orcontrol (VNSOFF) for a 6-monthperiod.Theprimary endpointwas the change in LVend systolic diameter (LVESD) at 6months for control vs. therapy, with secondary endpoints of other echocardiographymeasurements, exercise capacity, quality-of-life assessments, 24-hHolter, and circulating biomarkers. Results Of the 96 implanted patients, 87 had paired datasets for the primary endpoint. Change in LVESD from baseline to 6 months was-0.04 ± 0.25 cm in the therapy group compared with-0.08 ± 0.32 cm in the control group (P = 0.60). Additional echocardiographic parameters of LV end diastolic dimension, LV end systolic volume, left ventricular end diastolic volume, LV ejection fraction, peak V02, and N-terminal pro-hormone brain natriuretic peptide failed to show superiority compared to the control group. However, therewere statistically significant improvements in quality of life for the Minnesota Living with Heart Failure Questionnaire (P = 0.049), New York Heart Association class (P = 0.032), and the SF-36 Physical Component (P = 0.016) in the therapy group. Conclusion Vagal nerve stimulation as delivered in the NECTAR-HF trial failed to demonstrate a significant effect on primary and secondary endpoint measures of cardiac remodelling and functional capacity in symptomatic heart failure patients, but quality-of-life measures showed significant improvement
2015
36
7
425
433
http://eurheartj.oxfordjournals.org/
Autonomic nervous system; Heart failure; Vagal stimulation; Medicine (all); Cardiology and Cardiovascular Medicine
Zannad, Faiez; DE FERRARI, GAETANO; Tuinenburg, Anton E.; Wright, David; Brugada, Josep; Butter, Christian; Klein, Helmut; Stolen, Craig; Meyer, Scott; Stein, Kenneth M.; Ramuzat, Agnes; Schubert, Bernd; Daum, Doug; Neuzil, Petr; Botman, Cornelis; Castel, Maria Angeles; D'Onofrio, Antonio; Solomon, Scott D.; Wold, Nicholas; Ruble, Stephen B.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/1736618
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