Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355388
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-02-04
Brief Title:
TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure
Sponsor:
Fondazione Toscana Gabriele Monasterio
Organization:
Fondazione Toscana Gabriele Monasterio
Study Overview
Official Title:
TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAGUS-HF
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None