SCRATCH-HTN Study: Evaluating Autonomic Neuromodulation Using Trans-cutaneous Vagal Stimulation in Hypertensive Patients

Exclusion Criteria

• •1. Participant is unable and unwilling to use the AffeX-CT device daily.
• •2. Participant has a small tragus (ie. the size or shape of the tragus is such that it doesn't allow the application of the ear-clips of the AffeX-CT device for a sustained period of time).
• •3. Participant has a piercing on the tragus of the ear.
• •4. Participant is diagnosed with atrial fibrillation or other form of cardiac arrhythmia
• •5. Participant is known to have chronic kidney disease (CKD) stage 3b or higher or had eGFR \<45 ml/min/1.73 m2 in last three months prior to baseline (randomisation) visit.
• •6. Participant has type 1 diabetes mellitus.
• •7. Participant has type 2 diabetes mellitus on Insulin or those on oral antidiabetic medications with poor glycaemic control defined as HbA1c above 8.5% (or \>69 mmol/mol).
• •8. Participant has a history of falls or symptoms of orthostatic hypotension in the last 3 months prior to baseline (randomisation) visit.
• •9. Participant is pregnant, nursing or planning to become pregnant within the next 6 months.
• •10. Participant suffers from chronic pain and has taken anti-inflammatory drugs for two or more days per week over the last month prior to baseline (randomisation) visit.
• •11. Participant has clinically significant or symptomatic hypertension-mediated target organ damage such as severe heart failure with NYHA 4, end stage renal damage, medically diagnosed/imaging proven stroke, symptomatic peripheral vascular disease, or severe retinopathy.
• •12. Participant has a history of stable or unstable angina or had an acute coronary event within 3 months prior to baseline (randomisation) visit or had a myocardial infarction within the last six months of enrolment prior to baseline (randomisation) visit.
• •13. Participant has a history of renal denervation within last 1 year prior to baseline (randomisation) visit.
• •14. Participant has a therapeutic implantable electronic/electrical device such as pacemaker, implantable cardioverter-defibrillators (ICDs), implanted vagal stimulators.
• •15. Participant has history of hospitalization (\> 24 hour) for heart failure, or cerebrovascular accidents, or history of stroke diagnosed based on imaging or evidence of specialist diagnosis or any other indirect evidence such as discharge summary or clinical letter (at any time in the past).
• •16. Participant has mean daytime ABPM pulse pressure ≥ 80 mmHg at screening or baseline (randomisation) visit.
• •17. Participant has a heart rate \<50 bpm at screening or baseline (randomisation) visit (measurement taken after 5 minutes of rest in a seated position and when finger probe has been placed for a minimum of 30 seconds thereafter).
• •18. Participant has auricular dermatitis.
• •19. Participant has postural hypotension, defined as a fall \> 20mmHg in SBP on standing at 3 minutes (compared with sitting).
• •20. Participant has a history of hospitalization for hypertensive emergency or urgency in the last six months of enrolment prior to baseline (randomisation) visit.
• •21. Participant is identified as unsuitable to participate by the CI/Co-Investigator(s) and/or Investigation site team for another reason (e.g., for other medical reasons, laboratory abnormalities, limited life expectancy, etc.).
• •22. Participants with history of epilepsy and are currently on anti-epileptic medication or those who are not on any anti-epileptic medication but have history of a seizure within last 10 years.