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OpenTrials
Completed

NCT Number: NCT01823887

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

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chennai, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Vagus Nerve Stimulation (VNS)

Device

Electrical Stimulation of the Vagus Nerve

Primary outcomes

  1. Cardiac Function

    Time frame: 6 months

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

  2. Adverse Events

    Time frame: 6 months

    Incidence of procedure and device-related complications

Secondary outcomes

  1. Functional Status

    Time frame: 6 months

    6-minute walk test

  2. Quality of Life

    Time frame: 6 months

    Minnesota Living with Heart Failure Questionnaire

  3. Functional Status

    Time frame: 6 months

    New York Heart Association Class

  4. Autonomic Function

    Time frame: 6 months

    Heart Rate Variability (HRV)

  5. Blood Biomarkers

    Time frame: 6 months

    Blood Levels of Heart Failure Biomarkers

  6. Cardiac Function

    Time frame: 6 months

    Left ventricular end-systolic diameter (LVESD)

Sponsors and collaborators

Lead sponsor

Cyberonics, Inc.

Industry

Registry information

Acronym: ANTHEM-HF

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2013
Registry last updated
Feb 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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