TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure
- Conditions
- Heart Failure With Midrange Ejection FractionHeart FailureHeart Failure With Reduced Ejection Fraction
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Michele Emdin
🇮🇹Pisa, Pi, Italy
Michele Emdin🇮🇹Pisa, Pi, ItalyMichele Emdin, MD, PhDContactemdin@ftgm.itFrancesco Gentile, MDSub InvestigatorClaudio Passino, MDPrincipal Investigator