TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure

Prior treatment

• 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);

Other illness

• 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%);

Lab values

• Liver insufficiency (AST/ALT \>100 U/L and/or gamma-GT \>150 U/L);

Age

• 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).

Other

• Active neoplasia;
• Participation in other clinical studies in the 3 months preceding;

• 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.