NCT03163030

Brief Summary

The ANTHEM-HFpEF 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 with preserved and mid-range ejection fraction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

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

August 1, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

5.3 years

First QC Date

May 19, 2017

Last Update Submit

May 2, 2023

Conditions

Congestive Heart Failure

Keywords

Heart FailurePreserved Ejection FractionVNSVagus NerveAutonomic Regulation Therapy

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Incidence of procedure and device-related complications

    12 months

Secondary Outcomes (8)

  • Cardiac Size (LAVI)

    12 months

  • Functional Status (6MWD)

    12 months

  • Quality of Life Score

    12 months

  • Functional Status (NYHA Class)

    12 months

  • Cardiac Function (E/E')

    12 months

  • +3 more secondary outcomes

Study Arms (1)

Therapy

EXPERIMENTAL

Right Cervical Vagus Nerve Stimulation (VNS)

Device: Vagus Nerve Stimulation (VNS)

Interventions

Vagus Nerve Stimulation (VNS)DEVICE

Electrical Stimulation of the Vagus Nerve

Therapy

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 preserved and mid-range EF (≥40%).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krishna Institute of Medical Science

Secunderabad, India

Location

Related Publications (1)

  • Kumar HU, Nearing BD, Mittal S, Premchand RK, Libbus I, DiCarlo LA, Amurthur B, KenKnight BH, Anand IS, Verrier RL. Autonomic regulation therapy in chronic heart failure with preserved/mildly reduced ejection fraction: ANTHEM-HFpEF study results. Int J Cardiol. 2023 Jun 15;381:37-44. doi: 10.1016/j.ijcard.2023.03.030. Epub 2023 Mar 17.

    PMID: 36934987RESULT

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, Ph.D

    Cyberonics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2017

First Posted

May 22, 2017

Study Start

August 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2021

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)