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Clinical Trial
. 2014 Jun;16(6):692-9.
doi: 10.1002/ejhf.80. Epub 2014 May 20.

Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF

Gaetano M De Ferrari  1 , Anton E Tuinenburg, Stephen Ruble, Josep Brugada, Helmut Klein, Christian Butter, David J Wright, Bernd Schubert, Scott Solomon, Scott Meyer, Kenneth Stein, Agnes Ramuzat, Faiez Zannad
Affiliations
Clinical Trial

Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF

Gaetano M De Ferrari et al. Eur J Heart Fail. 2014 Jun.

Abstract

Aims: Increased sympathetic activation and reduced parasympathetic tone are important pathophysiological contributors to the progression of heart failure, and are associated with poor outcome in patients. The aim of this study is to determine if vagal nerve stimulation (VNS) is a promising approach to modulate autonomic function and slow cardiac remodelling and the progression of heart failure.

Methods: The NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) trial is designed to evaluate whether the Boston Scientific VNS device is safe and may attenuate cardiac remodelling, improve cardiac function and increase exercise capacity, in symptomatic heart failure patients (New York Heart Association Class II-III) with left ventricular systolic dysfunction (ejection fraction ≤35%) and receiving optimal medical therapy. Patients will be randomized in a 2:1 ratio to receive standard optimal medical treatment plus VNS system in an active mode vs. optimal medical treatment plus VNS system in an inactive mode, for a 6 month period. After the 6 month control period, inactive VNS systems will be activated and all patients will receive VNS. The study is powered to detect differences in the primary efficacy endpoint of change in left ventricular end systolic diameter. Secondary endpoints include ejection fraction, left ventricular volumes, quality of life scores, functional capacity, and changes in biomarkers.

Conclusion: This Phase II, randomized clinical trial conducted with vagal stimulation for heart failure will provide important new information on the potential of this novel and promising technique.

Keywords: Autonomic; Cardiac; Device; Heart; Parasympathetic; Vagal.

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Figures

Figure 1
Figure 1
The NCT lead is for investigational use only.
Figure 2
Figure 2
The NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) implant location. The lead is placed around the cervical vagus nerve and then tunnelled across the clavicle and connected to the pulse generator, which is located in a pectoral pocket.
Figure 3
Figure 3
Study flow chart and data collection. CPET, cardiopulmonary exercise test; HF, heart failure; LVEDD, left ventricular end diastolic diameter; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; QOL, quality of life.
See this image and copyright information in PMC

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