Evidence map›Paper›PMID 35023349›Full record

Trial reportJournal of the American Heart Association2022

Neuromodulation of Inflammation to Treat Heart Failure With Preserved Ejection Fraction: A Pilot Randomized Clinical Trial.

Stavros Stavrakis, Khaled Elkholey, Lynsie Morris, Monika Niewiadomska, Zain Ul Abideen Asad, Mary Beth Humphrey

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Heart Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05350150 (Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study), which is not on this map. Cited by 70 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 4 pooled it
7.3field-weighted citation impact, top 2% 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.

NCT05350150 naactive not recruitingnot on this map

Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study (VNS-EPS)

TypeinterventionalSponsorNorthwell HealthRan2022 to 2026Enrolled10ConditionsNeuromodulationArmsAuricular Vagal Nerve Stimulation
3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 4 syntheses or guidelines pooled it, 94 citations in OpenAlex.

  1. Vagus Nerve Stimulation in Movement Disorders, from Principles to a Systematic Review of Evidence.Movement disorders : official journal of the Movement Disorder Society · 2025
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Effect of transcutaneous vagus nerve stimulation in hemodialysis patients: A randomized controlled trial.Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy · 2026
    Trial
  6. Trial
  7. Acute right-sided transcutaneous vagus nerve stimulation improves cardio-vagal baroreflex gain in patients with chronic heart failure.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2025
    Trial
  8. Trial
  9. Noninvasive low-level tragus stimulation attenuates inflammation and oxidative stress in acute heart failure.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2023
    Trial
  10. Trial
  11. Hypertension: a missing piece in HFpEF?Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Neuroimmune interactions in cardiovascular homeostasis and disease.American journal of physiology. Cell physiology · 2026
    Review
  19. Pocking the Ear for HFpEF?Cardiovascular drugs and therapy · 2026
    Article
  20. Article

10 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Stavros StavrakisUniversity of Oklahoma Health Science Center Oklahoma City OK.ORCID 0000-0002-4370-8135
Khaled ElkholeyUniversity of Oklahoma Health Science Center Oklahoma City OK.
Lynsie MorrisUniversity of Oklahoma Health Science Center Oklahoma City OK.
Monika NiewiadomskaUniversity of Oklahoma Health Science Center Oklahoma City OK.
Zain Ul Abideen AsadUniversity of Oklahoma Health Science Center Oklahoma City OK.ORCID 0000-0003-3110-7049
Mary Beth HumphreyUniversity of Oklahoma Health Science Center Oklahoma City OK.ORCID 0000-0003-0042-4068
University of Oklahoma Health Sciences Center · US

Funding

Neuromodulation of Inflammation to Treat Heart Failure with Preserved Ejection FractionR21AG057879 · NIA · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI STAVRAKIS, STAVROS · 2018 to 2019
$407k
NIA NIH HHS R21 AG057879
6 · The paper itself

Abstract

Background A systemic proinflammatory state plays a central role in the development of heart failure with preserved ejection fraction. Low-level transcutaneous vagus nerve stimulation suppresses inflammation in humans. We conducted a sham-controlled, double-blind, randomized clinical trial to examine the effect of chronic low-level transcutaneous vagus nerve stimulation on cardiac function, exercise capacity, and inflammation in patients with heart failure with preserved ejection fraction. Methods and Results Patients with heart failure with preserved ejection fraction and at least 2 additional comorbidities (obesity, diabetes, hypertension, or age ≥65 years) were randomized to either active (tragus) or sham (earlobe) low-level transcutaneous vagus nerve stimulation (20 Hz, 1 mA below discomfort threshold), for 1 hour daily for 3 months. Echocardiography, 6-minute walk test, quality of life, and serum cytokines were assessed at baseline and 3 months. Fifty-two patients (mean age 70.4±9.2 years; 70% female) were included (active, n=26; sham, n=26). Baseline characteristics were balanced between the 2 arms. Adherence to the protocol of daily stimulation was >90% in both arms (

Indexed as

Heart FailureQuality of LifeAgedFemaleHumansInflammationMaleMiddle AgedPilot ProjectsStroke VolumeTumor Necrosis Factor-alphaVentricular Function, LeftTumor Necrosis Factor-alphaautonomic modulationheart failure with preserved ejection fractioninflammation

Identifiers

PMID35023349
PMCPMC9238491
OpenAlexW4205403017

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.