TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure

Not Applicable

Not yet recruiting

• Conditions: Heart Failure With Midrange Ejection Fraction; Heart Failure; Heart Failure With Reduced Ejection Fraction
• Interventions: Device: Sham tVNS; Device: Active tVNS

• Registration Number: NCT06355388
• Lead Sponsor: Fondazione Toscana Gabriele Monasterio

Brief Summary

To verify the efficacy of transcutaneous vagus nerve stimulation (tVNS) on and autonomic balance in patients with chronic heart failure and reduced (HFrEF) or mildly reduced (HFmrEF) left ventricular ejection fraction. The study hypothesis is that tVNS increases baroreflex gain, with consequent benefits on sympathovagal balance (at short- and mid-term), and on quality of life and bio-humoral parameters (at mid-term).

Detailed Description

Pilot phase: comparing the effects of right- (10-minute) vs. left-sided tVNS (10-minute) on BRS and heart rate variability (HRV) in a subset of patients.

Short-term phase: comparing the effects of active- (10-minute) vs. sham-tVNS (10-minute) on BRS, HRV, and sympathetic nerve activity.

Mid-term phase: comparing the effects of active- (4-week) vs- sham-tVNS (4-week) on BRS, HRV, biomarkers, exercise performance, and cardiac function.

Study Timeline

• Study First Submitted: 2024-02-04
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Study Start: 2024-05-01
• Primary Completion: 2025-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham tVNS	Sham tVNS	The ear clip of the device will be positioned at the level of the patient's tragus but not delivering current.
Active tVNS	Active tVNS	The ear clip of the device will be positioned at the level of the patient's tragus delivering current.

Primary Outcome Measures

Name	Time	Method
Mean change in baroreflex gain (ms/mmHg)	4 weeks (mid-term effect)	Barorefex gain will be calculated calculated as the ratio between the standard deviation of RR intervals (ms) and systolic blood pressure (mmHg)

Trial Locations

Locations (1)

Michele Emdin; 🇮🇹 Pisa, Pi, Italy