Tests a skin-applied vagus nerve device in people with chronic heart failure
Tests a skin-applied vagus nerve device against a sham device in adults with heart failure.
Plain-language title generated from the registry record
Registry title: TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure
Key facts
- Where
- Pisa, ItalySee the site
Where in Italy
- Michele EmdinPisa, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Toscana Gabriele Monasterio
- Trial code
- NCT06355388
- Record updated
- 9 April 2024
- Original description
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).Read full original descriptionShow less
TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure
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).
Inclusion: Aged ≥18 years; Ability to consent to enrollment; Diagnosis of chronic heart failure (CHF= and left ventricular ejection fraction <50% according to the latest European guidelines.
Exclusion: Clinical need to modify CHF therapy during the study; Unstable major psychiatric disorders or treatment with psychoactive drugs or drugs that can act on the autonomic nervous system (e.g., antidepressants, antipsychotics, opioids, benzodiazepines); History of acute coronary syndrome within 3 months of enrollment; History of recurrent syncope, orthostatic hypotension, severe bradycardia (average heart rate <50 bpm), or second or third-degree atrioventricular block; Neurological conditions characterized by dysautonomia (e.g., Parkinson's disease); Uncontrolled thyroid disorders; Severe renal insufficiency (estimated glomerular filtration rate <15 ml/min/1.73 m2); Moderate or severe chronic obstructive pulmonary disease (FEV1/FVC <70% of predicted and FEV1 <70%); Liver insufficiency (AST/ALT >100 U/L and/or gamma-GT >150 U/L); Women in pregnancy, breastfeeding, or of childbearing age not following adequate contraception (the woman must agree to abstain from heterosexual intercourse or use at least two effective contraceptive measures such as bilateral tubal ligation, male sterilization, use of hormonal contraceptives that inhibit ovulation, intrauterine devices releasing hormones, copper intrauterine devices; all barrier devices must be used in combination with a spermicidal cream); Active neoplasia; Participation in other clinical studies in the 3 months preceding.