Clinical trial NCT01385176: Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
Official title: Neural Cardiac Therapy for Heart Failure Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Congestive Heart Failure
Keywords: Heart failure
Congestive heart failure
New York Heart Association Class II-III
Vagal therapy
Vagal nerve stimulation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2011-06-30
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients were randomized in a 2:1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The primary endpoint was the change in LVend systolic diameter (LVESD) at 6 months for control vs. therapy, with secondary endpoints of other echocardiography measurements, exercise capacity, quality-of-life assessments, 24-h Holter, and circulating biomarkers.
Primary purpose: TREATMENT

Brief summary: The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms.

Detailed description: The objectives of this study are to assess the impact of right vagal nerve stimulation on left ventricular remodeling, functional capacity, quality of life, and other measures in heart failure patients over a 6-month period. In addition, the study will assess the safety of the NECTAR-HF study system over an 18-month period.

Eligibility criteria: Inclusion Criteria:

* Age 18 or above, and of legal age to give informed consent specific to national laws
* Willing and capable of providing informed consent
* Capable of participating in all testing associated with this clinical investigation
* Stable symptomatic heart failure NYHA class II-III
* Left ventricular (LV) ejection fraction equal or smaller than 35 %
* Left ventricular end diastolic diameter (LVEDD) of 5.5 cm or greater
* Prescribed to optimal pharmacologic therapy

Exclusion Criteria:

* QRS larger than 130 ms
* Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment
* Patients unable to tolerate anesthesia required for implant
* Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 90 days before enrollment
* Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification
* Patients with persistent or permanent atrial fibrillation within 90 days prior to enrollment
* Pacemaker indicated patients
* Patients whose heart failure is due to congenital heart disease
* Patients who have started treatment for sleep apnea or sleep disordered breathing with therapies to maintain airway patency (e.g., CPAP, Bi-PAP,APAP) with or without oxygen supplementation within the previous 6 months prior to enrollment
* Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
* Patients with documented chronic obstructive lung disease
* Patients on or indicated for renal dialysis
* Type 1 diabetic patients
* Type 2 diabetic patients that have been treated with insulin for more than 5 years prior to enrollment
* Patients with a life expectancy of less than 12 months per physician judgment
* Patients involved in any concurrent clinical investigation
* Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
* Patients with a prior cardiac transplant or expecting a heart transplant operation within the next 12 months
* Patients with a prior vagotomy
* Patients with prior or existing vagal nerve stimulation treatment
* Patients implanted with any active implantable medical device other than a left sided single or dual chamber implantable cardioverter defibrillator (ICD) with bipolar sensing, or a left sided CRT device with each sensing channel programmed to either bipolar sensing or no sensing. All CRT patients must have had CRT for at least 1 year prior to enrollment. The total number of CRT patients will not exceed 30
* Patients with locally implanted semi-/permanent devices such as vascular catheters, etc. that would interfere with the NECTAR-HF study system
* Patients with previously implanted devices on the right side that became infected before removal
* Patients with previous neck surgery and resultant scar formation that interferes with the ability to implant the study system on the right side of the neck (Thyroid/parathyroid, carotid artery etc)
* Patients with known recurrent nerve paralysis
* Patients who have undergone radiotherapy for thyroid disease/cancer
* Patients who have existing or prior tracheotomy
* Patients with severe vertebral cervical disease and limited mobility in the neck; includes those that frequently wear a brace
* Patients with carotid murmur/vascular bruit/carotid artery lesion
* Patients with known/suspected vascular malformation in carotid/vertebral circulatory bed
* Patients who are likely to need an MRI of the neck area because of previous medical conditions

Primary outcomes:
measure: Change in Left Ventricular End-systolic Dimension (LVESD)
timeFrame: LVESD at Baseline and at 6-months post Baseline
measure: Percentage of Surviving Participants
timeFrame: 18-months
Secondary outcomes:
measure: LVEF, Left Ventricular Ejection Fraction
timeFrame: LVEF at Baseline and at 6-months after Baseline
measure: Exercise Capacity, Peak VO2
timeFrame: Measurements at Baseline and at 6-months after Baseline
measure: LVESV, Left Ventricular End Systolic Volume
timeFrame: At Baseline and at 6-months after Baseline
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UCL Bruxelles
city: Prague
country: Czechia
facility: Nemocnice Na Homolce
city: Vandoeuvre les Nancy
country: France
facility: Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy
state: Nancy
city: Lille
country: France
facility: CHRU de Lille - Hôpital Cardiologique
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg
state: Brandenburg
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Milano
country: Italy
facility: Azienda Ospedaliera Niguarda Cà Granda
city: Napoli
country: Italy
facility: A. O. Dei Colli - Monaldi
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra, Avenida Pio XII s/n
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol, NHS Foundation Trust
state: England
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital, NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: The Heart Hospital, University College London Hospitals, NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust, St. Mary's Hospital
state: England
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
affiliation: Centre d'Investigation Clinique (CIC), Batiment Louis Mathieu, CHU de Nancy
name: Faiez Zannad, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Ferrari GM, Tuinenburg AE, Ruble S, Brugada J, Klein H, Butter C, Wright DJ, Schubert B, Solomon S, Meyer S, Stein K, Ramuzat A, Zannad F. Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF. Eur J Heart Fail. 2014 Jun;16(6):692-9. doi: 10.1002/ejhf.80. Epub 2014 May 20.
citation: Zannad F, De Ferrari GM, Tuinenburg AE, Wright D, Brugada J, Butter C, Klein H, Stolen C, Meyer S, Stein KM, Ramuzat A, Schubert B, Daum D, Neuzil P, Botman C, Castel MA, D'Onofrio A, Solomon SD, Wold N, Ruble SB. 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. Eur Heart J. 2015 Feb 14;36(7):425-33. doi: 10.1093/eurheartj/ehu345. Epub 2014 Aug 31.
citation: De Ferrari GM, Stolen C, Tuinenburg AE, Wright DJ, Brugada J, Butter C, Klein H, Neuzil P, Botman C, Castel MA, D'Onofrio A, de Borst GJ, Solomon S, Stein KM, Schubert B, Stalsberg K, Wold N, Ruble S, Zannad F. Long-term vagal stimulation for heart failure: Eighteen month results from the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial. Int J Cardiol. 2017 Oct 1;244:229-234. doi: 10.1016/j.ijcard.2017.06.036. Epub 2017 Jun 10.