TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure (TRAGUS-HF)

Fondazione Toscana Gabriele Monasterio

Status: Not yet enrolling

Conditions: Heart Failure With Midrange Ejection Fraction; Heart Failure With Reduced Ejection Fraction; Heart Failure

Treatments: Device: Active tVNS; Device: Sham tVNS

Study type: Interventional

Funder types: Other

Identifiers

NCT06355388

TRAGUSHF

Details and patient eligibility

About

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).

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• 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 criteria

• History of acute coronary syndrome within 3 months of enrollment;
• Clinical need to modify CHF therapy during the study;
• 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);
• 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);
• Uncontrolled thyroid disorders;
• Active neoplasia;
• 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);
• Participation in other clinical studies in the 3 months preceding;
• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Active tVNS

Experimental group

Description:

The ear clip of the device will be positioned at the level of the patient's tragus delivering current.

Treatment:

Device: Active tVNS

Sham tVNS

Placebo Comparator group

Description:

The ear clip of the device will be positioned at the level of the patient's tragus but not delivering current.

Treatment:

Device: Sham tVNS