Back to resultsAutonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Vagus Nerve Stimulation (VNS)
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Heart Failure, Preserved Ejection Fraction, VNS, Vagus Nerve, Autonomic Regulation Therapy
Eligibility Criteria
Inclusion Criteria:
Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with preserved and mid-range EF (≥40%).
Exclusion Criteria:
-
Sites / Locations
- Krishna Institute of Medical Science
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Therapy
Arm Description
Right Cervical Vagus Nerve Stimulation (VNS)
Outcomes
Primary Outcome Measures
Adverse Events
Incidence of procedure and device-related complications
Secondary Outcome Measures
Cardiac Size (LAVI)
Left atrial volume index
Functional Status (6MWD)
6-minute walk distance
Quality of Life Score
Minnesota Living with Heart Failure Questionnaire score
Functional Status (NYHA Class)
New York Heart Association classification
Cardiac Function (E/E')
Ratio of mitral velocity to early diastolic velocity of the mitral annulus
Cardiac Size (LV mass index)
Left ventricular mass index
Autonomic Function (HRV)
Heart rate variability
Blood Biomarkers
Blood Levels of Heart Failure Biomarkers (NT-proBNP, creatinine, C-reactive protein)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03163030
Brief Title
Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction
Official Title
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure With Preserved Ejection Fraction (ANTHEM-HFpEF) Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyberonics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Heart Failure, Preserved Ejection Fraction, VNS, Vagus Nerve, Autonomic Regulation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapy
Arm Type
Experimental
Arm Description
Right Cervical Vagus Nerve Stimulation (VNS)
Intervention Type
Device
Intervention Name(s)
Vagus Nerve Stimulation (VNS)
Intervention Description
Electrical Stimulation of the Vagus Nerve
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidence of procedure and device-related complications
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cardiac Size (LAVI)
Description
Left atrial volume index
Time Frame
12 months
Title
Functional Status (6MWD)
Description
6-minute walk distance
Time Frame
12 months
Title
Quality of Life Score
Description
Minnesota Living with Heart Failure Questionnaire score
Time Frame
12 months
Title
Functional Status (NYHA Class)
Description
New York Heart Association classification
Time Frame
12 months
Title
Cardiac Function (E/E')
Description
Ratio of mitral velocity to early diastolic velocity of the mitral annulus
Time Frame
12 months
Title
Cardiac Size (LV mass index)
Description
Left ventricular mass index
Time Frame
12 months
Title
Autonomic Function (HRV)
Description
Heart rate variability
Time Frame
12 months
Title
Blood Biomarkers
Description
Blood Levels of Heart Failure Biomarkers (NT-proBNP, creatinine, C-reactive protein)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with preserved and mid-range EF (≥40%).
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imad Libbus, Ph.D
Organizational Affiliation
Cyberonics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Krishna Institute of Medical Science
City
Secunderabad
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36934987
Citation
Kumar HU, Nearing BD, Mittal S, Premchand RK, Libbus I, DiCarlo LA, Amurthur B, KenKnight BH, Anand IS, Verrier RL. Autonomic regulation therapy in chronic heart failure with preserved/mildly reduced ejection fraction: ANTHEM-HFpEF study results. Int J Cardiol. 2023 Jun 15;381:37-44. doi: 10.1016/j.ijcard.2023.03.030. Epub 2023 Mar 17.
Results Reference
result
Learn more about this trial
Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction
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