Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study
NCT ID: NCT01823887
Last Updated: 2015-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2012-07-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Left Sided Stimulation
Left cervical Vagus Nerve Stimulation (VNS)
Vagus Nerve Stimulation (VNS)
Electrical Stimulation of the Vagus Nerve
Right Sided Stimulation
Right Cervical Vagus Nerve Stimulation (VNS)
Vagus Nerve Stimulation (VNS)
Electrical Stimulation of the Vagus Nerve
Interventions
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Vagus Nerve Stimulation (VNS)
Electrical Stimulation of the Vagus Nerve
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Cyberonics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Imad Libbus, PhD
Role: STUDY_DIRECTOR
Cyberonics, Inc.
Locations
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Chennai, , India
Countries
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References
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Dicarlo L, Libbus I, Amurthur B, Kenknight BH, Anand IS. Autonomic regulation therapy for the improvement of left ventricular function and heart failure symptoms: the ANTHEM-HF study. J Card Fail. 2013 Sep;19(9):655-60. doi: 10.1016/j.cardfail.2013.07.002.
Premchand RK, Sharma K, Mittal S, Monteiro R, Dixit S, Libbus I, DiCarlo LA, Ardell JL, Rector TS, Amurthur B, KenKnight BH, Anand IS. Autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure: results of the ANTHEM-HF trial. J Card Fail. 2014 Nov;20(11):808-16. doi: 10.1016/j.cardfail.2014.08.009. Epub 2014 Sep 1.
Libbus I, Premchand RK, Sharma K, Mittal S, Monteiro R, Amurthur B, KenKnight BH, DiCarlo LA, Anand IS. Persistent Autonomic Engagement and Cardiac Control After Four or More Years of Autonomic Regulation Therapy Using Vagus Nerve Stimulation. Front Physiol. 2022 Mar 11;13:853617. doi: 10.3389/fphys.2022.853617. eCollection 2022.
Nearing BD, Libbus I, Carlson GM, Amurthur B, KenKnight BH, Verrier RL. Chronic vagus nerve stimulation is associated with multi-year improvement in intrinsic heart rate recovery and left ventricular ejection fraction in ANTHEM-HF. Clin Auton Res. 2021 Jun;31(3):453-462. doi: 10.1007/s10286-021-00780-y. Epub 2021 Feb 16.
Nearing BD, Libbus I, Amurthur B, Kenknight BH, Verrier RL. Acute Autonomic Engagement Assessed by Heart Rate Dynamics During Vagus Nerve Stimulation in Patients With Heart Failure in the ANTHEM-HF Trial. J Cardiovasc Electrophysiol. 2016 Sep;27(9):1072-7. doi: 10.1111/jce.13017. Epub 2016 Jul 7.
Libbus I, Nearing BD, Amurthur B, KenKnight BH, Verrier RL. Autonomic regulation therapy suppresses quantitative T-wave alternans and improves baroreflex sensitivity in patients with heart failure enrolled in the ANTHEM-HF study. Heart Rhythm. 2016 Mar;13(3):721-8. doi: 10.1016/j.hrthm.2015.11.030. Epub 2015 Nov 18.
Other Identifiers
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C-01
Identifier Type: -
Identifier Source: org_study_id
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