TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure

NANot yet recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

May 1, 2025

Study Completion Date

May 1, 2027

Conditions
Heart FailureHeart Failure With Reduced Ejection FractionHeart Failure With Midrange Ejection Fraction
Interventions
DEVICE

Active tVNS

"As for the short-term phase, the ear clip of the Parasym device (Parasym, London, United Kingdom), containing the stimulation electrode, will be positioned at the level of the patient's tragus, and a 10-minute stimulation will be initiated with a pulse width of 200 μs, a frequency of 30 Hz, and an intensity of one mA lower than the patient's sensitivity threshold.~As fort he mid-term phase, a device will be given to the patient, which will be instructed to position the ear clip of the device at the level of the tragus and to set stimulation parameters as established in the laboratory (see above). Each patient will be asked to undergo at least one hour daily stimulation for a period of 4 weeks, reporting on a diary the timing and details of the each session."

DEVICE

Sham tVNS

"As for the short-term phase, the ear clip of the Parasym device (Parasym, London, United Kingdom), containing the stimulation electrode, will be positioned at the level of the patient's tragus for 10-minute but no current will be delivered.~As fort he mid-term phase, a device (configured to withhold power delivery) will be given to the patient, which will be instructed to position the ear clip of the device at the level of the tragus and to set stimulation parameters as established in the laboratory (see above). Each patient will be asked to undergo at least one hour daily stimulation for a period of 4 weeks, reporting on a diary the timing and details of the each session."

Trial Locations (1)

56120

Michele Emdin, Pisa

All Listed Sponsors
collaborator

A.O.U. Città della Salute e della Scienza

OTHER

lead

Fondazione Toscana Gabriele Monasterio

OTHER

NCT06355388 - TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure | Biotech Hunter | Biotech Hunter