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NCT05789147: TRANSFER

Transcutaneous Vagus Nerve Stimulation in Heart Failure

Completed NA Last updated 30 January 2025
What this trial tests

NA trial testing Active tVNS in Heart Failure With Preserved Ejection Fraction in 29 participants. Completed in 31 December 2024.

Timeline
15 June 2020
Primary endpoint
30 September 2024
31 December 2024

Quick facts

Lead sponsorIstituti Clinici Scientifici Maugeri SpA
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment29
Start date15 June 2020
Primary completion30 September 2024
Estimated completion31 December 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Who can join

Adults 18 to 70, any sex, with Heart Failure With Preserved Ejection Fraction or Heart Failure With Midrange Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Several studies have shown that alterations in autonomic nervous system function are implicated in the onset and progression of numerous cardiovascular diseases. Direct stimulation of the vagus nerve by means of a sleeve placed around the vagus nerve represents one of the methodologies proposed in the field of neuromodulation. This study, which is proposed as a pilot study for further application of the method in subjects with cardiovascular disease aims to verify and consolidate evidence on cardiovascular autonomic effects in patients with heart failure. Vagal stimulation will be achieved noninvasively by applying an external stimulator to the auricular site.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Impact of optimized transcutaneous auricular vagus nerve stimulation on cardiac autonomic profile in healthy subjects and heart failure patients.
    Maestri R, Pinna GD, Robbi E, Cogliati C, et al · · 2024 · cited 7× · PMID 39016202 · DOI 10.1088/1361-6579/ad5ef6
  2. Neuromodulation Therapies in Heart Failure: A State-of-the-Art Review.
    Pahuja M, Akhtar KH, Krishan S, Nasir YM, et al · · 2023 · cited 5× · PMID 39131073 · DOI 10.1016/j.jscai.2023.101199
  3. Treating heart failure by targeting the vagus nerve.
    Gentile F, Orlando G, Montuoro S, Ferrari Chen YF, et al · · 2024 · cited 5× · PMID 39117958 · DOI 10.1007/s10741-024-10430-w
  4. The mechanism and clinical research of vagus nerve electrical stimulation in the treatment of myocardial ischemia-reperfusion injury.
    Wang H, Zhang X, Li X, Xing J, et al · · 2026 · PMID 41716993 · DOI 10.1016/j.isci.2026.114657

Verify or expand the search:

Other trials of Active tVNS

Trials testing the same drug.

Other recruiting trials for Heart Failure With Preserved Ejection Fraction

Currently open trials in the same condition.

Other Istituti Clinici Scientifici Maugeri SpA trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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