We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Alexandra
Papa
-
a.papa@qmul.ac.uk
Dr
Ajay
Gupta
+44 2078822858
ajay.gupta@qmul.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Uncontrolled high blood pressure
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Hypertension/High blood pressure (BP) is the leading risk factor for death and illness from a cardiovascular event (e.g. heart attack), and managing high BP is a key focus of treatment for cardiovascular diseases. Antihypertensive drugs (drugs that aim to lower BP) are widely available, however a high number of people with high BP fail to achieve a healthy BP value despite receiving 1 or more anti-hypertensive medications. For uncontrolled hypertensive patients, including drug-resistant patients, the lack of an effective therapy is a major health challenge and an urgent unmet clinical need.
One potentially highly effective strategy to improve BP control in hypertension is via redressing the nervous system imbalance, which is linked with the development of hypertension; the brain controls the cardiovascular system by sending commands through the nervous system.
In this study, we will utilise a device that produces a very small electrical current to the nerves at the front area of the ears (the tragus). With this strategy, we aim to redress the nervous system imbalance and treat hypertension.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 17/04/2024:
1. Participant has given written informed consent.
2. Participant has sufficient knowledge of the English language to be able to understand the participant information sheet and trial materials including outcome assessments.
3. Participant is aged ≥18 years and <80 years at the time of screening visit.
4. Participant is taking between 1 to 4 antihypertensive medications (inclusive) at time of screening and baseline (randomisation) visit and is willing to adhere to no change in medication during the trial until end of the trial visit (visit 5). (NB. Participant on only one antihypertensive medication should be taking that medication for at least six weeks prior to the screening visit).
5. Participant has confirmed diagnosis of hypertension.
6. Participant meets the following BP criteria: 24-hour ambulatory BP monitoring (ABPM) at either screening visit or baseline (randomisation) visit, with mean daytime SBP of ≥135 mmHg and <170 mmHg and mean daytime DBP of >85 mm Hg and <115 mmHg (N.B. By default, Ambulatory Blood Pressure Monitoring [ABPM] at screening visit will be used at baseline visit. However, if there has been an addition of new medication after participants screening visit, 24-hour ABPM must be repeated at baseline visit).
7. Participant has one or more of the following associated conditions:
7.1. Obesity: BMI >30 OR waist circumference >94 cm (men) or > 80cm (women). (NB. For participants of South-East Asian/Chinese/Japanese origin these cut-offs are >90 cm (men) or >80 cm (women)).
7.2. Type 2 diabetes – controlled or sub-optimally controlled (HbA1c ≤8.5% or ≤69 mmol/mol) on diet and/ or medications except insulin.
7.3. Heart rate (on any one of the three heart rate recordings at that visit) ≥70 bpm at screening or baseline (randomisation) visit (measurements taken after 5 minutes of rest in a seated position and when finger probe has been placed for a minimum of 30 seconds thereafter) or a heart rate (on any one of the three heart rate recordings) ≥60 bpm at screening or baseline (randomisation) visit if the patient is taking beta-blocker medication.
7.4. HbA1c ≥42 mmol/mol or fasting blood glucose (if available) ≥5.6 mmo/L, and either low HDL cholesterol (≤1.03 mmol/L for men and ≤1.29 mmol/L for women) or high triglyceride (triglycerides ≥1.7 mmol/L)
7.5. Both low HDL cholesterol (≤1.03 mmol/L for men and ≤1.29 mmol/L for women) and high triglyceride (triglycerides ≥1.7 mmol/L)
7.6. Diagnosed or known case of polycystic ovarian syndrome.
8. Female participant of child-bearing potential (all those below 55 years except if they are surgically sterile, meaning they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy, or formally diagnosed by their doctors to be post-menopausal) must agree to use the acceptable methods of contraception from the time of consent until last follow up visit.
9. Participant is able to communicate satisfactorily with the Investigator and Investigation Site staff, and to participate in, and comply with all clinical study requirements
10. Participant agrees to have all trial procedures performed and are able and willing to comply with a
You may not be able to take part if:
Current exclusion criteria as of 17/04/2024:
1. Participant is unable and unwilling to use 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 has eGFR <45 ml/min/1.73 m2 at screening 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 hospitalisation 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/Sub-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.
_____
Previous 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 significant (or symptomatic) target organ damage including symptomatic heart failure, renal damage, 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 history of renal denervation within 1 year prior to baseline (randomisation) visit. 14. Participant has an implantable electronic/electrical device such as pacemaker, implantable cardioverter-defibrillators (ICDs), implanted vagal stimulators. 15. Participant has history of hospitalization for heart failure, cerebrovascular accidents, or stroke (at any time in the past). 16. Participant has mean office pulse pressure ≥80 mmHg (mean of the last two of the three readings) 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
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Alexandra
Papa
-
a.papa@qmul.ac.uk
Dr
Ajay
Gupta
+44 2078822858
ajay.gupta@qmul.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Queen Mary University of London and funded by NIHR Central Commissioning Facility (CCF); National Institute for Health Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 51314
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
