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

Congestive Heart Failure Clinical Trial

— ANTHEM-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823887
• Other study ID #: C-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 1, 2013
• Last updated: February 17, 2015
• Start date: July 2012
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: Cyberonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Vagus Nerve Stimulation (VNS)
Electrical Stimulation of the Vagus Nerve

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View Citation

Premchand RK, Sharma K, Mittal S, Monteiro R, Dixit S, Libbus I, DiCarlo LA, Ardell JL, Rector TS, Amurthur B, KenKnight BH, Anand IS. Autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Function	Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)	6 months	No
Primary	Adverse Events	Incidence of procedure and device-related complications	6 months	Yes
Secondary	Functional Status	6-minute walk test	6 months	No
Secondary	Quality of Life	Minnesota Living with Heart Failure Questionnaire	6 months	No
Secondary	Functional Status	New York Heart Association Class	6 months	No
Secondary	Autonomic Function	Heart Rate Variability (HRV)	6 months	No
Secondary	Blood Biomarkers	Blood Levels of Heart Failure Biomarkers	6 months	No
Secondary	Cardiac Function	Left ventricular end-systolic diameter (LVESD)	6 months	No