Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction

May 2, 2023 updated by: Cyberonics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Secunderabad, India
        • Krishna Institute of Medical Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapy
Right Cervical Vagus Nerve Stimulation (VNS)
Device: Vagus Nerve Stimulation (VNS)
Electrical Stimulation of the Vagus Nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 12 months
Incidence of procedure and device-related complications
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Size (LAVI)
Time Frame: 12 months
Left atrial volume index
12 months
Functional Status (6MWD)
Time Frame: 12 months
6-minute walk distance
12 months
Functional Status (NYHA Class)
Time Frame: 12 months
New York Heart Association classification
12 months
Cardiac Function (E/E')
Time Frame: 12 months
Ratio of mitral velocity to early diastolic velocity of the mitral annulus
12 months
Cardiac Size (LV mass index)
Time Frame: 12 months
Left ventricular mass index
12 months
Autonomic Function (HRV)
Time Frame: 12 months
Heart rate variability
12 months
Blood Biomarkers
Time Frame: 12 months
Blood Levels of Heart Failure Biomarkers (NT-proBNP, creatinine, C-reactive protein)
12 months
Quality of Life Score
Time Frame: 12 months
Minnesota Living with Heart Failure Questionnaire score
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyberonics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

May 19, 2017

First Submitted That Met QC Criteria

May 19, 2017

First Posted (Actual)

May 22, 2017

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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