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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01823887
First received: April 1, 2013
Last updated: February 7, 2014
Last verified: January 2014

April 1, 2013
February 7, 2014
July 2012
July 2014   (final data collection date for primary outcome measure)
  • Cardiac Function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Left ventricular end-systolic volume (LVESV), left ventricular end-systolic diameter (LVESD), and ejection fraction (EF)
  • Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Incidence of procedure and device-related complications
  • Cardiac Function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Composite of left ventricular end-systolic volume (LVESV), left ventricular end-systolic diameter (LVESD), and ejection fraction (EF)
  • Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Incidence of procedure and device-related complications
Complete list of historical versions of study NCT01823887 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Congestive Heart Failure
Device: Vagus Nerve Stimulation (VNS)
Electrical Stimulation of the Vagus Nerve
  • Experimental: Left Sided Stimulation
    Left cervical Vagus Nerve Stimulation (VNS)
    Intervention: Device: Vagus Nerve Stimulation (VNS)
  • Experimental: Right Sided Stimulation
    Right Cervical Vagus Nerve Stimulation (VNS)
    Intervention: Device: Vagus Nerve Stimulation (VNS)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with reduced EF and dilated hearts
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01823887
C-01
Yes
Cyberonics, Inc.
Cyberonics, Inc.
Not Provided
Study Director: Imad Libbus, PhD Cyberonics, Inc.
Cyberonics, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP