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


CONCLUSIONS
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.
Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Gaetano M
GM
De Ferrari
Anton E
AE
Tuinenburg
Stephen
S
Ruble
Josep
J
Brugada
Helmut
H
Klein
Christian
C
Butter
David J
DJ
Wright
Bernd
B
Schubert
Scott
S
Solomon
Scott
S
Meyer
Kenneth
K
Stein
Agnes
A
Ramuzat
Faiez
F
Zannad
D015415:Biomarkers; D018450:Disease Progression; D004452:Echocardiography; D005080:Exercise Test; D005500:Follow-Up Studies; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D011788:Quality of Life; D012107:Research Design; D013318:Stroke Volume; D016896:Treatment Outcome; D055536:Vagus Nerve Stimulation / Q000379:methods*; D018487:Ventricular Dysfunction, Left / Q000503:physiopathology*; D020257:Ventricular Remodeling
D015415:Biomarkers
Autonomic; Cardiac; Device; Heart; Parasympathetic; Vagal