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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01823887
First received: April 1, 2013
Last updated: September 23, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)

  • Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Incidence of procedure and device-related complications


Secondary Outcome Measures:
  • Functional Status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    6-minute walk test

  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Minnesota Living with Heart Failure Questionnaire

  • Functional Status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    New York Heart Association Class

  • Autonomic Function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Heart Rate Variability (HRV)

  • Blood Biomarkers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Blood Levels of Heart Failure Biomarkers

  • Cardiac Function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823887

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

Publications:
Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT01823887     History of Changes
Other Study ID Numbers: C-01
Study First Received: April 1, 2013
Last Updated: September 23, 2014
Health Authority: India: Drugs Controller General of India

Keywords provided by Cyberonics, Inc.:
Heart Failure
Vagus Nerve
VNS

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014