NCT01823887

Brief Summary

The ANTHEM-HF Study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with symptomatic heart failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

1.8 years

First QC Date

April 1, 2013

Last Update Submit

February 17, 2015

Conditions

Congestive Heart Failure

Keywords

Heart FailureVagus NerveVNS

Outcome Measures

Primary Outcomes (2)

  • Cardiac Function

    Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)

    6 months

  • Adverse Events

    Incidence of procedure and device-related complications

    6 months

Secondary Outcomes (6)

  • Functional Status

    6 months

  • Quality of Life

    6 months

  • Functional Status

    6 months

  • Autonomic Function

    6 months

  • Blood Biomarkers

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Left Sided Stimulation

EXPERIMENTAL

Left cervical Vagus Nerve Stimulation (VNS)

Device: Vagus Nerve Stimulation (VNS)

Right Sided Stimulation

EXPERIMENTAL

Right Cervical Vagus Nerve Stimulation (VNS)

Device: Vagus Nerve Stimulation (VNS)

Interventions

Vagus Nerve Stimulation (VNS)DEVICE

Electrical Stimulation of the Vagus Nerve

Left Sided StimulationRight Sided Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with reduced EF and dilated hearts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Chennai, India

Location

Related Publications (6)

  • Dicarlo L, Libbus I, Amurthur B, Kenknight BH, Anand IS. Autonomic regulation therapy for the improvement of left ventricular function and heart failure symptoms: the ANTHEM-HF study. J Card Fail. 2013 Sep;19(9):655-60. doi: 10.1016/j.cardfail.2013.07.002.

    PMID: 24054343BACKGROUND

  • Premchand RK, Sharma K, Mittal S, Monteiro R, Dixit S, Libbus I, DiCarlo LA, Ardell JL, Rector TS, Amurthur B, KenKnight BH, Anand IS. Autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure: results of the ANTHEM-HF trial. J Card Fail. 2014 Nov;20(11):808-16. doi: 10.1016/j.cardfail.2014.08.009. Epub 2014 Sep 1.

    PMID: 25187002RESULT

  • Libbus I, Premchand RK, Sharma K, Mittal S, Monteiro R, Amurthur B, KenKnight BH, DiCarlo LA, Anand IS. Persistent Autonomic Engagement and Cardiac Control After Four or More Years of Autonomic Regulation Therapy Using Vagus Nerve Stimulation. Front Physiol. 2022 Mar 11;13:853617. doi: 10.3389/fphys.2022.853617. eCollection 2022.

    PMID: 35360224DERIVED

  • Nearing BD, Libbus I, Carlson GM, Amurthur B, KenKnight BH, Verrier RL. Chronic vagus nerve stimulation is associated with multi-year improvement in intrinsic heart rate recovery and left ventricular ejection fraction in ANTHEM-HF. Clin Auton Res. 2021 Jun;31(3):453-462. doi: 10.1007/s10286-021-00780-y. Epub 2021 Feb 16.

    PMID: 33590355DERIVED

  • Nearing BD, Libbus I, Amurthur B, Kenknight BH, Verrier RL. Acute Autonomic Engagement Assessed by Heart Rate Dynamics During Vagus Nerve Stimulation in Patients With Heart Failure in the ANTHEM-HF Trial. J Cardiovasc Electrophysiol. 2016 Sep;27(9):1072-7. doi: 10.1111/jce.13017. Epub 2016 Jul 7.

    PMID: 27221316DERIVED

  • Libbus I, Nearing BD, Amurthur B, KenKnight BH, Verrier RL. Autonomic regulation therapy suppresses quantitative T-wave alternans and improves baroreflex sensitivity in patients with heart failure enrolled in the ANTHEM-HF study. Heart Rhythm. 2016 Mar;13(3):721-8. doi: 10.1016/j.hrthm.2015.11.030. Epub 2015 Nov 18.

    PMID: 26601770DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Imad Libbus, PhD

    Cyberonics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2013

First Posted

April 4, 2013

Study Start

July 1, 2012

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

February 19, 2015

Record last verified: 2015-02

Locations

IN(1)