Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)

Heart Failure Clinical Trial

— NECTAR-HF  

Official title:

Neural Cardiac Therapy for Heart Failure Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01385176
• Other study ID #: NECTAR-1109
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 21, 2011
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: June 30, 2025
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Implant of investigational device system
Vagus nerve stimulation lead was wrapped around the right cervical vagus nerve and then connected to a stimulator permanently implanted in the right pectoral region.

Procedure:
• Titration during the randomization phase
Amplitude of the chronically delivered vagus nerve stimulation in the experimental arm was adjusted to the highest tolerable by patient value. No chronically delivered vagus nerve stimulation in the control arm during the randomization phase.
• Titration after the randomization phase
Amplitude of the chronically delivered vagus nerve stimulation was adjusted to the highest tolerable by patient value in all patients in both arms of the study.

Diagnostic Test:
• Blood Draw
Blood draw before implant and 6 months after implant at the end of the randomization phase.

Locations

Country	Name	City	State
Belgium	UCL Bruxelles	Brussels
Czechia	Nemocnice Na Homolce	Prague
France	CHRU de Lille - Hôpital Cardiologique	Lille
France	Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy	Vandoeuvre les Nancy	Nancy
Germany	Immanuel Klinikum Bernau Herzzentrum Brandenburg	Bernau	Brandenburg
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitätsklinikum Leipzig	Leipzig
Italy	Azienda Ospedaliera Niguarda Cà Granda	Milano
Italy	A. O. Dei Colli - Monaldi	Napoli
Italy	Policlinico San Matteo	Pavia
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven
Netherlands	UMC Utrecht	Utrecht
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Doce de Octubre	Madrid
Spain	Clínica Universitaria de Navarra, Avenida Pio XII s/n	Pamplona	Navarra
United Kingdom	University Hospitals Bristol, NHS Foundation Trust	Bristol	England
United Kingdom	Liverpool Heart and Chest Hospital, NHS Foundation Trust	Liverpool	England
United Kingdom	Imperial College Healthcare NHS Trust, St. Mary's Hospital	London	England
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	The Heart Hospital, University College London Hospitals, NHS Foundation Trust	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

References & Publications (3)

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 failur — View 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. — View 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 treatme — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Left Ventricular End-systolic Dimension (LVESD)	Change in the Left ventricular end-systolic dimension (LVESD) between Baseline and the value at the end of the randomization phase (6 months after Baseline) i.e. 6 months after vagus nerve stimulation in the THERAPY Arm. No Vagus nerve stimulation during that time window in the CONTROL Arm.; The sign (- ) indicates a reduction in the LVESD. Minus means a reduction in LVESD.; The change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline).	LVESD at Baseline and at 6-months post Baseline
Primary	Percentage of Surviving Participants	As pre-specified in the study protocol, the All-cause Survival endpoint combined both groups into one analysis population. Subjects contributed data according to the follow-up period during they received VNS therapy (Implant through 18 months for Therapy subjects, 6 through 18 months for Control subjects). Control patients who exited the study in the first 6 months, or who did not have a 6 month visit, were excluded.	18-months
Secondary	LVEF, Left Ventricular Ejection Fraction	LVEF, left ventricular ejection fraction.	LVEF at Baseline and at 6-months after Baseline
Secondary	Exercise Capacity, Peak VO2	Assessment of functional capacity (e.g., peak VO2) as measures related to patient heart failure status.	Measurements at Baseline and at 6-months after Baseline
Secondary	LVESV, Left Ventricular End Systolic Volume	Measurements of LVESV, left ventricular end systolic volume at Baseline and 6 months after Baseline in the Control Arm and in the Therapy Arm	At Baseline and at 6-months after Baseline