Clinical trial NCT06355388: TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure
Official title: TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Heart Failure With Midrange Ejection Fraction
Lead sponsor: Fondazione Toscana Gabriele Monasterio
Sponsor class: OTHER
Collaborators: name: A.O.U. Città della Salute e della Scienza
First posted: 2024-04-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Mean change in baroreflex gain (ms/mmHg)
timeFrame: 10 minutes (short-term effect)
measure: Mean change in baroreflex gain (ms/mmHg)
timeFrame: 4 weeks (mid-term effect)
Secondary outcomes:
Other outcomes:
measure: Mean change in MSNA burst incidence (bursts/100 heartbeats)
timeFrame: 10 minutes (short-term effect)
measure: Mean change in peak O2 consumption (mL/Kg/min)
timeFrame: 4 weeks (mid-term effect)
Locations:
city: Pisa
country: Italy
facility: Michele Emdin
state: Pi
Study officials:
References: