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Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study (ANTHEM-HF)

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Vagus Nerve Stimulation (VNS)
Sponsored by
Cyberonics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Heart Failure, Vagus Nerve, VNS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Left Sided Stimulation

Right Sided Stimulation

Arm Description

Left cervical Vagus Nerve Stimulation (VNS)

Right Cervical Vagus Nerve Stimulation (VNS)

Outcomes

Primary Outcome Measures

Cardiac Function
Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)
Adverse Events
Incidence of procedure and device-related complications

Secondary Outcome Measures

Functional Status
6-minute walk test
Quality of Life
Minnesota Living with Heart Failure Questionnaire
Functional Status
New York Heart Association Class
Autonomic Function
Heart Rate Variability (HRV)
Blood Biomarkers
Blood Levels of Heart Failure Biomarkers
Cardiac Function
Left ventricular end-systolic diameter (LVESD)

Full Information

First Posted
April 1, 2013
Last Updated
February 17, 2015
Sponsor
Cyberonics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01823887
Brief Title
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study
Acronym
ANTHEM-HF
Official Title
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyberonics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Heart failure patients will be enrolled and randomized to cervical VNS implantation on either the left side or right side. After a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 6 months, with data collection at 3 months and 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Heart Failure, Vagus Nerve, VNS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Left Sided Stimulation
Arm Type
Experimental
Arm Description
Left cervical Vagus Nerve Stimulation (VNS)
Arm Title
Right Sided Stimulation
Arm Type
Experimental
Arm Description
Right Cervical Vagus Nerve Stimulation (VNS)
Intervention Type
Device
Intervention Name(s)
Vagus Nerve Stimulation (VNS)
Intervention Description
Electrical Stimulation of the Vagus Nerve
Primary Outcome Measure Information:
Title
Cardiac Function
Description
Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)
Time Frame
6 months
Title
Adverse Events
Description
Incidence of procedure and device-related complications
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Functional Status
Description
6-minute walk test
Time Frame
6 months
Title
Quality of Life
Description
Minnesota Living with Heart Failure Questionnaire
Time Frame
6 months
Title
Functional Status
Description
New York Heart Association Class
Time Frame
6 months
Title
Autonomic Function
Description
Heart Rate Variability (HRV)
Time Frame
6 months
Title
Blood Biomarkers
Description
Blood Levels of Heart Failure Biomarkers
Time Frame
6 months
Title
Cardiac Function
Description
Left ventricular end-systolic diameter (LVESD)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with reduced EF and dilated hearts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imad Libbus, PhD
Organizational Affiliation
Cyberonics, Inc.
Official's Role
Study Director
Facility Information:
City
Chennai
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
24054343
Citation
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.
Results Reference
background
PubMed Identifier
25187002
Citation
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.
Results Reference
result
PubMed Identifier
35360224
Citation
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.
Results Reference
derived
PubMed Identifier
33590355
Citation
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.
Results Reference
derived
PubMed Identifier
27221316
Citation
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.
Results Reference
derived
PubMed Identifier
26601770
Citation
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.
Results Reference
derived

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Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study

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