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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01823887
First Posted: April 4, 2013
Last Update Posted: February 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cyberonics, Inc.
  Purpose
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.

Condition Intervention Phase
Congestive Heart Failure Device: Vagus Nerve Stimulation (VNS) Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study

Resource links provided by NLM:


Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • Cardiac Function [ Time Frame: 6 months ]
    Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)

  • Adverse Events [ Time Frame: 6 months ]
    Incidence of procedure and device-related complications


Secondary Outcome Measures:
  • Functional Status [ Time Frame: 6 months ]
    6-minute walk test

  • Quality of Life [ Time Frame: 6 months ]
    Minnesota Living with Heart Failure Questionnaire

  • Functional Status [ Time Frame: 6 months ]
    New York Heart Association Class

  • Autonomic Function [ Time Frame: 6 months ]
    Heart Rate Variability (HRV)

  • Blood Biomarkers [ Time Frame: 6 months ]
    Blood Levels of Heart Failure Biomarkers

  • Cardiac Function [ Time Frame: 6 months ]
    Left ventricular end-systolic diameter (LVESD)


Enrollment: 60
Study Start Date: July 2012
Study Completion Date: June 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Left Sided Stimulation
Left cervical Vagus Nerve Stimulation (VNS)
Device: Vagus Nerve Stimulation (VNS)
Electrical Stimulation of the Vagus Nerve
Experimental: Right Sided Stimulation
Right Cervical Vagus Nerve Stimulation (VNS)
Device: Vagus Nerve Stimulation (VNS)
Electrical Stimulation of the Vagus Nerve

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with reduced EF and dilated hearts
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823887


Locations
India
Chennai, India
Sponsors and Collaborators
Cyberonics, Inc.
Investigators
Study Director: Imad Libbus, PhD Cyberonics, Inc.