Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163030
• Other study ID #: C-04
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2021

Study information

• Verified date: May 2023
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2021
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Vagus Nerve Stimulation (VNS)
Electrical Stimulation of the Vagus Nerve

Locations

Country	Name	City	State
India	Krishna Institute of Medical Science	Secunderabad

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Country where clinical trial is conducted

India, 

References & Publications (1)

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 Ca — View Citation

Outcome

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