TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Fondazione Toscana Gabriele Monasterio
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Mean change in baroreflex gain (ms/mmHg)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Michele Emdin
Professor
Fondazione Toscana Gabriele Monasterio
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mean change in baroreflex gain (ms/mmHg)
Time Frame: 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)