Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction


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Verified May 2017 by Cyberonics, Inc.

Sponsor:

Information provided by (Responsible Party):

Cyberonics, Inc.

ClinicalTrials.gov Identifier:

NCT03163030

First received: May 19, 2017

Last updated: May 19, 2017

Last verified: May 2017

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.

Congestive Heart Failure Device: Vagus Nerve Stimulation (VNS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure With Preserved Ejection Fraction (ANTHEM-HFpEF) Study

Primary Outcome Measures:

Secondary Outcome Measures:

  • Cardiac Size (LAVI) [ Time Frame: 12 months ]

    Left atrial volume index

  • Functional Status (6MWD) [ Time Frame: 12 months ]

    6-minute walk distance

  • Quality of Life [ Time Frame: 12 months ]

    Minnesota Living with Heart Failure Questionnaire score

  • Functional Status (NYHA Class) [ Time Frame: 12 months ]

    New York Heart Association classification

  • Cardiac Function (E/E’) [ Time Frame: 12 months ]

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

  • Cardiac Size (LV mass index) [ Time Frame: 12 months ]

    Left ventricular mass index

  • Autonomic Function (HRV) [ Time Frame: 12 months ]

    Heart rate variability

  • Blood Biomarkers [ Time Frame: 12 months ]

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

Estimated Enrollment: 50
Study Start Date: August 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Experimental: Therapy

Right Cervical Vagus Nerve Stimulation (VNS)

Device: Vagus Nerve Stimulation (VNS)

Electrical Stimulation of the Vagus Nerve

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03163030

Krishna Institute of Medical Science
Secunderabad, India
Contact: Rajendra Kumar Premchand, MD       kumarpre@hotmail.com   

Cyberonics, Inc.

Study Director: Imad Libbus, Ph.D Cyberonics, Inc.

Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT03163030     History of Changes
Other Study ID Numbers: C-04
Study First Received: May 19, 2017
Last Updated: May 19, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cyberonics, Inc.:

Heart Failure
Preserved Ejection Fraction
VNS
Vagus Nerve
Autonomic Regulation Therapy

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2017