Evidence map›Paper›PMID 29283224›Full record

Trial reportESC heart failure2018

Autonomic regulation therapy to enhance myocardial function in heart failure patients: the ANTHEM-HFpEF study.

Lorenzo A DiCarlo, Imad Libbus, H Uday Kumar, Sanjay Mittal, Rajendra K Premchand, Badri Amurthur, Bruce H KenKnight, Jeffrey L Ardell, Inder S Anand

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in ESC heart failure, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Hypertension: a missing piece in HFpEF?Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Review
  5. Single-Electrode, Bidirectional Control of Heart Rate via Vagus Nerve Modulation in Rat Model.IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society · 2026
    Article
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  7. Article
  8. Review
  9. Review
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  11. Review
  12. Review
  13. Review
  14. Article
  15. Device Therapy in Chronic Heart Failure: JACC State-of-the-Art Review.Journal of the American College of Cardiology · 2021
    Review
  16. Review
  17. Article
  18. Article
  19. Review
  20. Optogenetic Control of the Peripheral Nervous System.Cold Spring Harbor perspectives in medicine · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 3 countries.

Lorenzo A DiCarloLivaNova PLC, London, UK.
Imad LibbusLivaNova PLC, London, UK.
H Uday KumarYashoda Hospital, Secunderabad, India.
Sanjay MittalMedanta-The Medicity, New Delhi, India.
Rajendra K PremchandKrishna Institute of Medical Science, Secunderabad, India.
Badri AmurthurLivaNova PLC, London, UK.
Bruce H KenKnightLivaNova PLC, London, UK.
Jeffrey L ArdellUniversity of California-Los Angeles, Los Angeles, CA, USA.
Inder S AnandMinneapolis VA Health Care System, University of Minnesota, Cardiology 111 C, One Veterans Drive, Minneapolis, MN, 55417, USA.
LivaNova (United Kingdom) · GBKrishna Institute of Medical Sciences · INMedanta The Medicity · INMinneapolis VA Health Care System · USUniversity of California, Los Angeles · USYashoda Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApproximately half of the patients presenting with new-onset heart failure (HF) have HF with preserved left ventricular ejection fraction (HFpEF) and HF with mid-range left ventricular ejection fraction (HFmrEF). These patients have neurohormonal activation like that of HF with reduced ejection fraction; however, beta-blockers and angiotensin-converting enzyme inhibitors have not been shown to improve their outcomes, and current treatment for these patients is symptom based and empiric. Sympathoinhibition using parasympathetic stimulation has been shown to improve central and peripheral aspects of the cardiac nervous system, reflex control, induce myocyte cardioprotection, and can lead to regression of left ventricular hypertrophy. Beneficial effects of autonomic regulation therapy (ART) using vagus nerve stimulation (VNS) have also been observed in several animal models of HFpEF, suggesting a potential role for ART in patients with this disease.

methodsThe Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Patients with Heart Failure and Preserved Ejection Fraction (ANTHEM-HFpEF) study is designed to evaluate the feasibility, tolerability, and safety of ART using right cervical VNS in patients with chronic, stable HFpEF and HFmrEF. Patients with symptomatic HF and HFpEF or HFmrEF fulfilling the enrolment criteria will receive chronic ART with a subcutaneous VNS system attached to the right cervical vagus nerve. Safety parameters will be continuously monitored, and cardiac function and HF symptoms will be assessed every 3 months during a post-titration follow-up period of at least 12 months.

conclusionsThe ANTHEM-HFpEF study is likely to provide valuable information intended to expand our understanding of the potential role of ART in patients with chronic symptomatic HFpEF and HFmrEF.

Indexed as

AgedAged, 80 and overFeasibility StudiesFemaleFollow-Up StudiesHeart FailureHumansMaleMiddle AgedPilot ProjectsStroke VolumeTreatment OutcomeVagus Nerve StimulationVentricular Function, LeftAutonomic balanceAutonomic regulation therapyHeart failureNeuromodulationPreserved ejection fractionVagus nerve stimulation

Identifiers

PMID29283224
PMCPMC5793957
OpenAlexW2781377767

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.