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

Conditions

Congestive Heart Failure

Keywords

Heart Failure, Vagus Nerve, VNS

Brief 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.

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.

Imad Libbus, Rajendra Kumar Premchand, Kamal Sharma, Sanjay Mittal, Rufino Monteiro et al. (9 authors)

Frontiers in Physiology2022-03-113 citations

10.3389/fphys.2022.853617

Chronic vagus nerve stimulation is associated with multi-year improvement in intrinsic heart rate recovery and left ventricular ejection fraction in ANTHEM-HF.

Nearing BD, Libbus I, Carlson GM, Amurthur B, KenKnight BH, Verrier RL.

2021-02-1611 citations

10.1007/s10286-021-00780-y

Multi-year improvement in autonomic tone, baroreceptor sensitivity, and cardiac electrical stability using vagus nerve stimulation in patients with HFrEF in the ANTHEM-HF study

Bruce D. Nearing, Imad Libbus, Inder S. Anand, Lorenzo A. DiCarlo, Bruce H. KenKnight et al. (6 authors)

European Heart Journal2020-11-01

10.1093/ehjci/ehaa946.1118

Novel method to assess intrinsic heart rate recovery in ambulatory ECG recordings tracks cardioprotective effects of chronic autonomic regulation therapy in patients enrolled in the ANTHEM-HF study.

Carlson GM, Libbus I, Amurthur B, KenKnight BH, Verrier RL.

2017-02-175 citations

10.1111/anec.12436

Autonomic regulation therapy suppresses quantitative T-wave alternans and improves baroreflex sensitivity in patients with heart failure enrolled in the ANTHEM-HF study.

Libbus I, Nearing BD, Amurthur B, KenKnight BH, Verrier RL.

2015-11-1841 citations

10.1016/j.hrthm.2015.11.030

Interventions

DEVICEVagus Nerve Stimulation (VNS)

Electrical Stimulation of the Vagus Nerve

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Cardiac Function	6 months	Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)
Adverse Events	6 months	Incidence of procedure and device-related complications

Secondary

Measure	Time frame	Description
Autonomic Function	6 months	Heart Rate Variability (HRV)
Functional Status	6 months	6-minute walk test
Cardiac Function	6 months	Left ventricular end-systolic diameter (LVESD)
Blood Biomarkers	6 months	Blood Levels of Heart Failure Biomarkers
Quality of Life	6 months	Minnesota Living with Heart Failure Questionnaire

Countries

India

Outcome results

None listed