Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction

Not Applicable

Completed

• Conditions: Congestive Heart Failure

• Registration Number: NCT03163030
• Lead Sponsor: Cyberonics, Inc.

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Primary Completion: 2019-12
• Study Completion: 2021-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse Events	12 months	Incidence of procedure and device-related complications

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Krishna Institute of Medical Science; 🇮🇳 Secunderabad, India