Skip to main content
OpenTrials
Completed

NCT Number: NCT03163030

Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction

The ANTHEM-HFpEF 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 with preserved and mid-range ejection fraction.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krishna Institute of Medical Science

Secunderabad, India

About this study

Heart failure patients will be enrolled and implanted with a cervical VNS system on the right side. After a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 12 months, with data collection at 3, 6, 9, and 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with preserved and mid-range EF (≥40%).

Exclusion criteria

-

Treatment and study plan

Vagus Nerve Stimulation (VNS)

Device

Electrical Stimulation of the Vagus Nerve

Primary outcomes

  1. Adverse Events

    Time frame: 12 months

    Incidence of procedure and device-related complications

Secondary outcomes

  1. Cardiac Size (LAVI)

    Time frame: 12 months

    Left atrial volume index

  2. Functional Status (6MWD)

    Time frame: 12 months

    6-minute walk distance

  3. Quality of Life Score

    Time frame: 12 months

    Minnesota Living with Heart Failure Questionnaire score

  4. Functional Status (NYHA Class)

    Time frame: 12 months

    New York Heart Association classification

  5. Cardiac Function (E/E')

    Time frame: 12 months

    Ratio of mitral velocity to early diastolic velocity of the mitral annulus

  6. Cardiac Size (LV mass index)

    Time frame: 12 months

    Left ventricular mass index

  7. Autonomic Function (HRV)

    Time frame: 12 months

    Heart rate variability

  8. Blood Biomarkers

    Time frame: 12 months

    Blood Levels of Heart Failure Biomarkers (NT-proBNP, creatinine, C-reactive protein)

Sponsors and collaborators

Lead sponsor

Cyberonics, Inc.

Industry

Registry information

Official study title

Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure With Preserved Ejection Fraction (ANTHEM-HFpEF) Study

Important dates

Study start
2014
Primary completion
2019
Study completion
2021
First posted
May 22, 2017
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.